Trial Condition(s):
Lymphoma, Non-Hodgkin
Study of copanlisib in combination with standard immunochemotherapy in relapsed indolent non-Hodgkin’s lymphoma (iNHL) (CHRONOS-4)
Bayer Identifier:
17833
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.
Inclusion Criteria
: - Histologically confirmed diagnosis of B lymphocyte antigen CD20 positive iNHL with histological subtype limited to: -- Follicular lymphoma G1-2-3a -- Small lymphocytic lymphoma with absolute lymphocyte count <5x10E9/L at study entry -- Lymphoplasmacytoid lymphoma / Waldenström macroglobulinemia (LPL / WM) -- Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal) - Patients must have relapsed (recurrence after complete response or presented progression after partial response) or progressed after at least one but at most three prior lines of therapy, including rituximab, and/or rituximab biosimilars, and/or anti-CD20 monoclonal antibody (e.g. obinutuzumab) -based immunochemotherapy and alkylating agents (if given concomitantly is considered one line of therapy). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy with single agent rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody can be considered a previous regimen in the case the patient responded to it); at least 2 consecutive cycles of polychemotherapy; autologous transplant; or radioimmunotherapy. Previous exposure to other PI3K Inhibitors (except copanlisib) is acceptable provided there is no resistance (resistance defined as no response (response defined as partial response [PR] or complete response [CR]) at any time during therapy, or progressive disease (PD) after any response (PR/CR) or after stable disease within 6 months from the end of the therapy with a PI3K inhibitor. - Non-WM patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL this requirement may be restricted to splenomegaly alone since that is usually the only manifestation of measurable disease. - Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal and positive immunofixation test. - Male or female patients ≥ 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 - Life expectancy of at least 3 months - Availability of fresh tumor tissue and/or archival tumor tissue at Screening - Adequate baseline laboratory values as assessed within 7 days before starting study treatment. - Left ventricular ejection fraction ≥ 50%
Exclusion Criteria
- Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended. - Rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody (e.g. obinutuzumab) resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last date of rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody administration, including maintenance with these drugs). - HbA1c > 8.5% at screening - History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator) - Known lymphomatous involvement of the central nervous system - Known history of human immunodeficiency virus (HIV) infection - Hepatitis B (HBV) or hepatitis C (HCV) infection. Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy as per rituximab label. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA. - Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.CMV PCR test is considered positive if, the result can be interpreted as a CMV viremia according to local standard of care. - Uncontrolled hypertension despite optimal medical management (per investigator´s assessment) - Congestive heart failure > New York Heart Association (NYHA) class 2
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations The Alfred Hospital Prahran, Australia, 3181 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum der Universität München Grosshadern München, Germany, 81377 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Münster (UKM) Münster, Germany, 48149 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HUS, Meilahden sairaala Helsinki, Finland, 00290 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tampereen yliopistollinen sairaala, keskussairaala Tampere, Finland, 33521 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Singapore Singapore, Singapore, 169610 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10002 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rigshospitalet Copenhagen, Denmark, 2100 | Status Active, not recruiting | Contact Us: E-mail: clin[email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Dupuytren LIMOGES CEDEX, France, 87042 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de la Milétrie POITIERS, France, 86021 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojew. Szpital Specjalistyczny im. M. Kopernika Lodz, Poland, 93-513 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samsung Medical Center Seoul, South Korea, 06351 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Clinica Puerta de Hierro Majadahonda, Spain, 28222 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano, Italy, 20089 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fiona Stanley Hospital Murdoch, Australia, 6961 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dokuz Eylul Universitesi Tip Fakultesi Izmir, Turkey, 35340 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi Istanbul, Turkey, 34899 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ashford Cancer Centre Research Pty Ltd Kurralta Park, Australia, 5037 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 100 34 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Memorial Sloan Kettering Cancer Center New York, United States, 10021 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gabrail Cancer Center Canton, United States, 44718 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Union Medicine Centre (People's Hospital of Tianjin) Tianjin, China, 300121 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 1st Affiliated Hospital of Zhejiang University Hangzhou, China, 310000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhejiang Cancer Hospital Hangzhou, China, 310022 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fudan University Shanghai Cancer Center Shanghai, China, 200030 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 1st Affiliated hospital of Soochow University Suzhou, China, 215006 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fifth Medical Center, General Hospital of the Chinese People Beijing, China, 100071 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FuJian Medical University Union Hospital Fuzhou, China, 350001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Friendship Hospital, Capital Medical University Beijing, China, 100050 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jiangsu Cancer Hospital Nanjing, China, 210009 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singleton Hospital Swansea, United Kingdom, SA2 8QA | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dorset County Hospital Dorchester, United Kingdom, DT1 2JY | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West China Hospital Sichuan University Chengdu, China, 610041 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oulun yliopistollinen sairaala Oulu, Finland, 90020 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Turun yliopistollinen keskussairaala Turku, Finland, 20520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shamir Medical Center (Assaf Harofeh) Zerifin, Israel, 6093000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mater Misericordiae Hospital Dublin, Ireland, D07 R2WY | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cork University Hospital Cork, Ireland | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Universitaire de Sante de l'Estrie Sherbrooke, Canada, J1H 5N4 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Recherche soins intensifs, hôpital Maisonneuve-Rosemont Montréal, Canada, H1T 2M4 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital de L'Enfant Jesus Quebec City, Canada, G1J 1Z4 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Calvary Mater Hospital Newcastle Waratah, Australia, 2298 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Nacional del Cáncer Santiago, Chile, 838-0455 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigaciones Clínicas Vina del Mar Ltda. Vina del Mar, Chile, 2540364 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint Louis PARIS, France, 75010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint-Eloi MONTPELLIER CEDEX, France, 34295 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. George's Hospital London, United Kingdom, SW17 OQT | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Guangdong Provincial People's Hospital Guangzhou, China, 510100 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Medical University Cancer Institiute & Hospital Tianjin, China, 300060 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwick Park Hospital Harrow, United Kingdom, HA1 3UJ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Devon & Exeter Hospital Exeter, United Kingdom, EX2 5AX | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cheng Kung University Hospital Tainan, Taiwan, China, 704 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi" Ancona, Italy, 60126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Narodny onkologicky ustav Bratislava, Slovakia, 833 10 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universite de Grenoble Grenoble, France, 38043 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre François Magendie - Pessac PESSAC, France, 33600 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ankara Universitesi Tip Fakultesi Hastanesi Ankara, Turkey, 06100 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Karadeniz Teknik Universitesi Tip Fakultesi Trabzon, Turkey, 61080 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erciyes Universitesi Tip Fakultesi Kayseri, Turkey, 38039 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine Shanghai, China, 200092 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Istanbul Tip Fakultesi Istanbul, Turkey, 34093 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jilin Cancer Hospital Changchun, China, 130000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Henan Cancer Hospital Zhengzhou, China, 450008 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tumor Hospital of Hebei Province Shijiazhuang, China, 050011 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prince of Wales Hospital Hong Kong Shatin, Hong Kong, China | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg Halle, Germany, 06120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 50005 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ege Universitesi Tip Fakultesi Izmir, Turkey, 35100 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Trakya Univ. Tip Fak. Edirne, Turkey, 22030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ondokuz Mayis Uni Tip Fakultesi Samsun, Turkey, 55139 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Jules Bordet/Jules Bordet Instituut BRUXELLES - BRUSSEL, Belgium, 1000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Liège LIEGE, Belgium, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Alberts Stem Cell Transplant Research Centre Pretoria, South Africa, 0044 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Outeniqua Cancercare Oncology Unit George, South Africa, 6530 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancercare Langenhoven Port Elizabeth, South Africa, 6045 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institute of Blood Pathology and Transfusion medicine Lviv, Ukraine, 79044 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Institute-Ukraine Kiev, Ukraine, 03022 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zaporizhzhia Regional Clinical Hospital Zaporizhzhya, Ukraine, 69600 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cherkasy Oncological Dispensary Cherkasy, Ukraine, 18009 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IPO Porto Porto, Portugal, 4200-072 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office Vila Nova de Gaia, Portugal, 4434-502 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Clinico Academico - Braga Braga, Portugal, 4710-243 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Multidisciplinar de Estudos Clínicos EPP - Ltda. Santo Andre, Brazil | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Odense OUH, Haematologisk afdeling Odense C, Denmark, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Català d'Oncologia Hospitalet L'Hospitalet de Llobregat, Spain, 08907 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Regional de Malaga | Oncologia Malaga, Spain, 29010 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario Lozano Blesa Zaragoza, Spain, 50009 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Affiliated Hospital of Qingdao University Qingdao, China, 266500 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gemeinschaftspraxis Dr.Heinrich/ Prof.Bangerter Augsburg, Germany, 86150 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Català d'Oncologia Badalona Badalona, Spain, 08916 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Flinders Medical Centre Adelaide, Australia, 5042 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LAIKO General Hospital of Athens Athens, Greece, 115 26 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Athens "ATTIKON" Chaidari, Greece, 12462 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations EVANGELISMOS General Hospital of Athens Athens, Greece, 106 76 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Patras Patras, Greece, 26500 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Univ. General Hospital of Larissa Larissa, Greece, 41100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de Clínicas de Porto Alegre Porto Alegre, Brazil, 90035-903 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Israelita Albert Einstein Sao Paulo, Brazil, 05651-901 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Nacional do Cancer Jose Alencar Gomes da Silva Rio de Janeiro, Brazil, 20230 130 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Pesquisas Oncológicas Florianópolis, Brazil, 88034-000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Integrado de Oncologia de Curitiba Curitiba, Brazil, 80810-050 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Sveti Georgi Plovdiv, Bulgaria, 4002 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Multiprofile Hosp. for Active Treat. Sveti Ivan Sofia, Bulgaria, 1431 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD Sofia, Bulgaria, 1756 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment Hristo Botev AD Vratsa, Bulgaria, 3000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis University Budapest, Hungary, 1083 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7624 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar, Hungary, 7400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szent Borbala Hospital Tatabanya, Hungary, 2800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis University Budapest, Hungary, 1088 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncology Dispensary #2 Sochi, Russia, 354057 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Clinical Oncology Dispensary Ufa Ufa, Russia, 450054 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations RSRI of Hematology and Transfusiology Saint-Petersburg, Russia, 191024 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Siberian State Medical University Tomsk, Russia, 634050 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncologianova GmbH Recklinghausen, Germany, 45659 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Health Integrated Renal Service Box Hill, Australia, 3128 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stauferklinikum Schwäbisch-Gmünd Mutlangen, Germany, 73557 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singapore General Hospital Singapore, Singapore, 169856 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National University Hospital Singapore, Singapore, 119228 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Hospital Chuo-ku, Japan, 104-0045 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tohoku University Hospital Sendai, Japan, 980-8574 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya City University Hospital Nagoya, Japan, 467-8602 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kobe University Hospital Kobe, Japan, 650-0017 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Orszagos Onkologiai Intezet Budapest, Hungary, 1122 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Research Institute of Oncology Rostov-on-Don, Russia, 344037 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Oncological Dispensary of Omsk Region Omsk, Russia, 644013 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kemerovo Regional Clinical Hospital Kemerovo, Russia, 650066 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pramongkutklao Hospital Bangkok, Thailand, 10400 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General de México SS Ciudad de México, Mexico, 06729 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Malopolskie Centrum Medyczne Krakow, Poland, 30-510 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Morski im. PCK Gdynia, Poland, 81-519 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations S.C. Policlinica de Diagnostic Rapid S.A. Brasov, Romania, 500152 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare Baia Mare, Romania, 430031 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundeni Clinical Institute Bucharest, Romania, 022328 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalul Clinic Colentina Bucuresti, Romania, 020125 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalul Clinic Coltea Bucharest, Romania, 030171 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institutul Regional de Oncologie Iasi Iasi, Romania, 700111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalul Clinic Municipal Filantropia Craiova Craiova, Romania, 200143 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Intercommunal de la Côte Basque-Bayonne BAYONNE, France, 64100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigación Clínica Chapultepec S.A. de C.V. Morelia, Mexico, 58260 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lewis Hall Singletary Oncology Center Thomasville, United States, 31792 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chaim Sheba Medical Center Ramat Gan, Israel, 5262000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IEP São Lucas São Paulo, Brazil, 01236-030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital das Clínicas da Faculdade de Medicina da USP São Paulo, Brazil, 05403-000. | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Faculdade de Ciencias Medicas-Universidade Estadual Campinas Campinas, Brazil, 130839 970 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire - Angers Angers, France, 49100 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Kyushu Cancer Center Fukuoka, Japan, 811-1395 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aichi Cancer Center Hospital Nagoya, Japan, 464-8681 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka Metropolitan University Hospital Osaka, Japan, 545-8586 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yamagata University Hospital Yamagata, Japan, 990-9585 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Cancer Center Akashi, Japan, 673-8558 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aomori Prefectural Central Hospital Aomori, Japan, 030-8553 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Kumamoto Medical Center Kumamoto, Japan, 860-0008 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SzSzBMK es EOK Josa Andras Oktatokorhaz Nyiregyhaza, Hungary, 4400 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique Saint Anne STRASBOURG, France, 67000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marienhospital Herne Universitätsklinik Herne, Germany, 44625 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Brian J. LeBerthon, MD West Covina, United States, 91790 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Constantiaberg Medi Clinic Cape Town, South Africa, 7800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sociedad de Investigaciones Medicas Ltda Temuco, Chile, 4810469 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations New York Cancer and Blood Specialists Port Jefferson Station, United States, 11776 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr. Chandler, United States, 85224 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SCL Health Research at St Joseph's Hospital Denver CO Denver, United States, 80218 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Especializado en Investigación Clínica S.C. Boca del Río, Mexico, 94290 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Atencion e Investigacion Clinica en Oncologia SCP Merida, Mexico, 97134 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Hochschule Hannover (MHH) Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncology Consultants Houston, United States, 77030 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre, Brazil, 90050 170 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario "José Eleuterio González" Monterrey, Mexico, 64460 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital du Sacre-Coeur de Montreal Montreal, Canada, QC H4J 1C5 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Texas Oncology- McAllen McAllen, United States, 78503 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multidisciplinary Clinical Hosp. 4 Dnipro Dnipro, Ukraine, 49102 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kindai University Hospital Osakasayama, Japan, 589-8511 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kumamoto University Hospital Kumamoto, Japan, 860-8556 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saitama Medical University International Medical Center Hidaka, Japan, 350-1298 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations JCHO Kyushu Hospital Kitakyushu, Japan, 806-8501 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Hotel Dieu - Nantes NANTES CEDEX, France, 44093 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique Victor Hugo - Le Mans LE MANS CEDEX 2, France, 72015 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier de la Durance - Avignon AVIGNON, France, 84000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hiroshima Red Cross & Atomic-bomb Survivors Hospital Hiroshima, Japan, 730-8619 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka Red Cross Hospital Osaka, Japan, 543-8555 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanagawa Cancer Center Yokohama, Japan, 241-8515 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tenri Hospital Tenri, Japan, 632-8552 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalul Clinic Judetean de Urgenta Sibiu Sibiu, Romania, 550245 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A Phase III, randomized, double-blind, controlled multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-Hodgkin’s lymphoma (iNHL)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Safety run-in_Determination of the recommended Phase-III dose (RP3D) of copanlisib in combination with standard immunochemotherapy assessed by the occurrence of dose-limiting toxicities / adverse eventsTimeframe: At Cycle 1: 21 days or 28 days
- Phase III_Evaluation whether copanlisib in combination with standard immunochemotherapy is superior to placebo and standard immunochemotherapy assessed by the prolongation of progression free survival (PFS)Progression free survival is defined as the time (in days) from randomization to disease progression or death from any cause (if no progression documented).Timeframe: Up to 52 months
Secondary Outcome
- Safety run-in_Best Overall Response (BOR)Timeframe: After Cycle 1: Up to 12 months
- Safety run-in_Number of participants with treatment-emergent adverse eventsTimeframe: Up to 13 months
- Phase III_Objective tumor response rate (ORR)Proportion of patients who have a best overall response over the whole duration of the study (i.e. up to time of analysis of PFS) of complete response (CR) or partial response (PR) according to the Lugano Classification and for patients with Waldenström macroglobulinemia a best overall response of CR, very good partial response (VGPR), PR, or minor response (MR) according to the Owen Criteria.Timeframe: Up to 52 months
- Phase III_Duration of tumor response (DOR)Time (in days) from first observed tumor response (complete response [CR], very good partial response [VGPR], partial response [PR], or minor response [MR]) until PD or death from any cause, whichever is earlier. DOR will only be analyzed for patients with at least one CR, VGPR, PR, or MR.Timeframe: Up to 52 months
- Phase III_Complete tumor response rate (CRR)Proportion of patients who have a best overall response of CR during the study (i.e., up to time of analysis of PFS).Timeframe: Up to 52 months
- Phase III_Time to tumor progression (TTP)Time from randomization to PD or death related to PD, whichever is earlier.Timeframe: Up to 52 months
- Phase III_Time to next anti-lymphoma treatment (TTNT)Time from stop of study medication to start of new anti-lymphoma therapy.Timeframe: Up to 52 months
- Phase III_Overall survival (OS)The time (in days) from randomization until death from any cause.Timeframe: Up to 5 years after last patient´s first treatment
- Phase III_Time to improvement in disease-related physical symptoms measured by Lymphoma Symptom Index-18 questionnaireTime to improvement in disease-related physical symptoms (DRS-P) is defined as time from randomization to first increase in DRS-P score of at least 3 points from baseline before tumor progression. Will be evaluated for patients with a baseline DRS-P score of 30 points or less. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire measures disease-specific symptoms and/or treatment-related concerns in patients with advanced lymphoma.Timeframe: Up to 52 months
- Phase III_Time to deterioration in disease-related physical symptoms measured by Lymphoma Symptom Index-18 questionnaireTime to deterioration in disease-related physical symptoms (DRS-P) is defined as time (in days) from randomization to the earliest occurrence of 1) first reduction of DRS-P score from baseline ≥ 3 points, or 2) radiological progression or biochemical progression for Waldenström macroglobulinemia patients without lesions evaluable by imaging, or 3) death from any cause. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire measures disease-specific symptoms and/or treatment-related concerns in patients with advanced lymphoma.Timeframe: Up to 52 months
- Phase III_Number of participants with treatment-emergent adverse eventsTimeframe: Up to 52 months
Additional Information
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