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
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Locations The Alfred Hospital Prahran, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum der Universität München Grosshadern München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Münster (UKM) Münster, Germany, 48149 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HUS, Meilahden sairaala Helsinki, Finland, 00290 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tampereen yliopistollinen sairaala, keskussairaala Tampere, Finland, 33521 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Singapore Singapore, Singapore, 169610 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rigshospitalet Copenhagen, Denmark, 2100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Dupuytren LIMOGES CEDEX, France, 87042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de la Milétrie POITIERS, France, 86021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojew. Szpital Specjalistyczny im. M. Kopernika Lodz, Poland, 93-513 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samsung Medical Center Seoul, South Korea, 06351 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Clinica Puerta de Hierro Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fiona Stanley Hospital Murdoch, Australia, 6961 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dokuz Eylul Universitesi Tip Fakultesi Izmir, Turkey, 35340 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi Istanbul, Turkey, 34899 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ashford Cancer Centre Research Pty Ltd Kurralta Park, Australia, 5037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 100 34 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Memorial Sloan-Kettering Cancer Center New York, United States, 10021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gabrail Cancer Center Canton, United States, 44718 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Union Medicine Centre (People's Hospital of Tianjin) Tianjin, China, 300121 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 1st Affiliated Hospital of Zhejiang University Hangzhou, China, 310000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhejiang Cancer Hospital Hangzhou, China, 310022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fudan University Shanghai Cancer Center Shanghai, China, 200030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 1st Affiliated hospital of Soochow University Suzhou, China, 215006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fifth Medical Center, General Hospital of the Chinese People Beijing, China, 100071 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FuJian Medical University Union Hospital Fuzhou, China, 350001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Friendship Hospital, Capital Medical University Beijing, China, 100050 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jiangsu Cancer Hospital Nanjing, China, 210009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singleton Hospital Swansea, United Kingdom, SA2 8QA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dorset County Hospital Dorchester, United Kingdom, DT1 2JY | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West China Hospital Sichuan University Chengdu, China, 610041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oulun yliopistollinen sairaala Oulu, Finland, 90020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Turun yliopistollinen keskussairaala Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shamir Medical Center (Assaf Harofeh) Zerifin, Israel, 6093000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mater Misericordiae Hospital Dublin, Ireland, D07 R2WY | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cork University Hospital Cork, Ireland | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Universitaire de Sante de l'Estrie Sherbrooke, Canada, J1H 5N4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Maisonneuve-Rosemont Montreal, Canada, H1T 2M4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital de L'Enfant Jesus Quebec City, Canada, G1J 1Z4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Calvary Mater Hospital Newcastle Waratah, Australia, 2298 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Nacional del Cáncer Santiago, Chile, 838-0455 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint Louis PARIS, France, 75010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Saint-Eloi MONTPELLIER CEDEX, France, 34295 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St George's Hospital London, United Kingdom, SW17 0QT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Guangdong Provincial People's Hospital Guangzhou, China, 510100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Medical University Cancer Institiute & Hospital Tianjin, China, 300060 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 3722 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwick Park Hospital Harrow, United Kingdom, HA1 3UJ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Devon & Exeter Hospital Exeter, United Kingdom, EX2 5AX | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cheng Kung University Hospital Tainan, Taiwan, China, 704 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione IRCCS Policlinico San Matteo Pavia, Italy, 27100 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Narodny onkologicky ustav Bratislava, Slovakia, 833 10 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universite de Grenoble Grenoble, France, 38043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre François Magendie - Pessac PESSAC, France, 33600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ankara Universitesi Tip Fakultesi Hastanesi Ankara, Turkey, 6100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Karadeniz Teknik Universitesi Tip Fakultesi Trabzon, Turkey, 61080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erciyes Universitesi Tip Fakultesi Kayseri, Turkey, 38039 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Istanbul Tip Fakultesi Istanbul, Turkey, 34093 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jilin Cancer Hospital Changchun, China, 130000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Henan Cancer Hospital Zhengzhou, China, 450008 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tumor Hospital of Hebei Province Shijiazhuang, China, 050011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prince of Wales Hospital Hong Kong Shatin, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg Halle, Germany, 06120 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 50005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ege Universitesi Tip Fakultesi Izmir, Turkey, 35100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Trakya Univ. Tip Fak. Edirne, Turkey, 22030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ondokuz Mayis Uni Tip Fakultesi Samsun, Turkey, 55139 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Jules Bordet/Jules Bordet Instituut BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Alberts Stem Cell Transplant Research Centre Pretoria, South Africa, 0044 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Outeniqua Cancercare Oncology Unit George, South Africa, 6530 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cancercare Langenhoven Port Elizabeth, South Africa, 6045 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations State Institution - Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine Lviv, Ukraine, 79044 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Governmental Noncommercial Institution "National Cancer Institute Kyiv, Ukraine, 03022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council Zaporizhzhya, Ukraine, 69600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council" Cherkasy, Ukraine, 18009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IPO Porto Porto, Portugal, 4200-072 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Clinico Academico - Braga Braga, Portugal, 4710-243 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Multidisciplinar de Estudos Clínicos EPP - Ltda. Santo Andre, Brazil | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Odense OUH, Haematologisk afdeling Odense C, Denmark, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Català d'Oncologia Hospitalet Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Regional de Malaga | Oncologia Malaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario Lozano Blesa Zaragoza, Spain, 50009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Affiliated Hospital of Qingdao University Qingdao, China, 266500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gemeinschaftspraxis Dr.Heinrich/ Prof.Bangerter Augsburg, Germany, 86150 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Català d'Oncologia Badalona Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Flinders Medical Centre Bedford Park, Australia, 5042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LAIKO General Hospital of Athens Athens, Greece, 115 26 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Athens "ATTIKON" Chaidari, Greece, 12462 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations EVANGELISMOS General Hospital of Athens Athens, Greece, 106 76 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Patras Patras, Greece, 26500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Univ. General Hospital of Larissa Larissa, Greece, 41100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de Clínicas de Porto Alegre Porto Alegre, Brazil, 90035-903 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department Sao Paulo, Brazil, 05651-901 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Pesquisas Oncológicas Florianópolis, Brazil, 88034-000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Integrado de Oncologia de Curitiba Curitiba, Brazil, 80810-050 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Sveti Georgi Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Multiprofile Hosp. for Active Treat. Sveti Ivan Sofia, Bulgaria, 1431 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment Hristo Botev AD Vratsa, Bulgaria, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis University Budapest, Hungary, 1083 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7624 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar, Hungary, 7400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya, Hungary, 2800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis University Budapest, Hungary, 1088 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncology Dispensary #2 Sochi, Russia, 354057 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Clinical Oncology Dispensary Ufa Ufa, Russia, 450054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations RSRI of Hematology and Transfusiology Saint-Petersburg, Russia, 191024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Siberian State Medical University Tomsk, Russia, 634050 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncologianova GmbH Recklinghausen, Germany, 45659 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Health Integrated Renal Service Box Hill, Australia, 3128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stauferklinikum Schwäbisch-Gmünd Mutlangen, Germany, 73557 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singapore General Hospital Singapore, Singapore, 169856 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National University Hospital Singapore, Singapore, 119228 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Center Hospital Chuo-ku, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tohoku University Hospital Sendai, Japan, 980-8574 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagoya City University Hospital Nagoya, Japan, 467-8602 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kobe University Hospital Kobe, Japan, 650-0017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Orszagos Onkologiai Intezet Budapest, Hungary, 1122 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Research Institute of Oncology Rostov-on-Don, Russia, 344037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Oncological Dispensary of Omsk Region Omsk, Russia, 644013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kemerovo Regional Clinical Hospital Kemerovo, Russia, 650066 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pramongkutklao Hospital Bangkok, Thailand, 10400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General de México SS Ciudad de México, Mexico, 06729 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Malopolskie Centrum Medyczne Krakow, Poland, 30-510 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Morski im. PCK Gdynia, Poland, 81-519 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations S.C. Policlinica de Diagnostic Rapid S.A. Brasov, Romania, 500152 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundeni Clinical Institute Bucharest, Romania, 022328 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalul Clinic Colentina Bucuresti, Romania, 020125 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalul Clinic Coltea Bucharest, Romania, 030171 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institutul Regional de Oncologie Iasi Iasi, Romania, 700111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spitalul Clinic Municipal Filantropia Craiova Craiova, Romania, 200143 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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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
- Phase III_Disease control rate (DCR)Proportion of patients who have a best response rating of CR, VGPR, PR, MR, or stable disease (SD) (excluding unconfirmed early SD) that is achieved during treatment or within 35 days after termination of study treatment.Timeframe: Up to 52 months
Additional Information
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