check_circleStudy Completed

Lymphoma, Non-Hodgkin

Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin's lymphomas

Trial purpose

The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin’s Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study.
In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.
After an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).
Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient completed treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. The end of study notification to Health Authorities will be based on the completion of the collection of survival data.
The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis (mandatory) and for central pathology review (part B), fresh biopsy tissue will also be collected if available.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Indolent NHL:
     -- Histologically confirmed diagnosis of follicular lymphoma (FL) grades 1, 2 or 3a, marginal zone lymphoma (including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue [MALT] lymphoma), lymphoplasmacytic lymphoma/Waldenström macroglobulinemia, chronic lymphocytic leukemia (CLL).
     -- Relapsed after ≥ 2 prior chemotherapy- or immunotherapy-based regimens for indolent NHL, or refractory to 2 prior chemotherapy and/ or immunotherapy-based regimens.
    - Aggressive NHL:
     -- Histologically confirmed diagnosis of grade 3b follicular lymphoma (FL), transformed indolent lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal large B-cell lymphoma, mantle cell lymphoma (MCL), peripheral T-cell lymphoma unspecified, or anaplastic large cell lymphoma primary systemic type, or angioimmunoblastic T cell lymphoma.
     -- Relapsed after ≥ 2 prior chemotherapy regimens, including the following: First-line treatment with standard anthracycline-containing regimen (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone or equivalent). At least 1 additional combination chemotherapy regimen. Patients relapsed after or refractory to first prior chemotherapy- and/or immunotherapy-based regimen for aggressive NHL and not eligible for high-dose regimen followed by transplant. High-dose chemotherapy, or chemoradiotherapy with autologous stem cell transplantation is considered 1 regimen. Patients with CD20 expressing neoplastic cells must have received prior rituximab, if available.
     -- Patients with transformed indolent lymphoma must have received at least 2 prior chemotherapy- and/or immunotherapy-based regimens
     -- Consent to provide fresh tumor tissue during screening
    - Indolent B-cell NHL lymphoma (study part B):
     -- Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
     --- Follicular lymphoma (FL) grade 1-2-3a
     --- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 109/L at the time of diagnosis and at study entry
     --- Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
     --- Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)
     -- Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received Rituximab and alkylating agents.
    - For all patients:
     -- Male or female patients > 18 years of age
     -- ECOG performance status ≤ 2 (ECOG: Eastern Cooperative Oncology Group)
     -- Life expectancy of at least 3 months
     -- Adequate bone marrow, liver and renal function as assessed within 7 days before starting study treatment
     -- Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) for the Institution
     -- Availability of archival tumor tissue
  • - Uncontrolled hypertension (blood pressure ≥ 150/90 mmHg despite optimal medical management)
    - Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks of start of study medication (CTCAE: Common Terminology Criteria for Adverse Events).
    - History or concurrent condition of interstitial lung disease
    - Unresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any prior therapy/procedure excluding alopecia. (NCI: National Cancer Institute)
    - Prior treatment with PI3K inhibitors
    - Systemic corticosteroid therapy (ongoing)
    - Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV RNA.
    - For Part B:
     -- Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease and chronic lymphocytic leukemia (CLL)
     -- History or concurrent condition of interstitial lung disease or severely impaired pulmonary function
    - Excluded medical conditions:
     -- Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
     -- Hepatitis B or C. All subjects must be screened for hepatitis B and C up to 28 days prior to study drug start using the hepatitis virus panel laboratorial routine. Subjects positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA.
     -- Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at screening.
     -- Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].

Trial summary

Enrollment Goal
227
Trial Dates
November 2012 - May 2023
Phase
Phase 2
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Bologna, 40138, Italy
Completed
Torino, 10126, Italy
Completed
Roma, 00161, Italy
Completed
Napoli, 80131, Italy
Completed
Manchester, M20 4BX, United Kingdom
Completed
LILLE, 59037, France
Completed
Pierre Benite, 69495, France
Completed
Creteil, 94010, France
Completed
Majadahonda, 28222, Spain
Completed
Barcelona, 08036, Spain
Completed
Valencia, 46026, Spain
Completed
Sevilla, 41071, Spain
Completed
Marbella, 29603, Spain
Completed
Bruxelles, 1070, Belgium
Withdrawn
ANTWERPEN, 2020, Belgium
Completed
GENT, 9000, Belgium
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
LEUVEN, 3000, Belgium
Completed
San Antonio, 78229, United States
Completed
Sutton, SM2 5PT, United Kingdom
Completed
Leeds, LS9 7TF, United Kingdom
Completed
PESSAC, 33600, France
Completed
München, 81377, Germany
Completed
Berlin, 13353, Germany
Completed
Mainz, 55131, Germany
Withdrawn
Homburg, 66424, Germany
Completed
Southampton, SO16 6YD, United Kingdom
Completed
Liverpool, L7 8XP, United Kingdom
Completed
Plymouth, PL6 8DH, United Kingdom
Completed
PARIS cedex, 75475, France
Completed
Helsinki, 00290, Finland
Completed
Turku, FIN-20521, Finland
Withdrawn
Jyväskylä, 40620, Finland
Completed
Rouen, 76038, France
Completed
Saint John, E2L 4L2, Canada
Completed
Montreal, H3T 1E2, Canada
Completed
St. Louis Park, 55426, United States
Withdrawn
Lake Success, 11042, United States
Withdrawn
Morristown, 07962-1089, United States
Withdrawn
Westwood, 66205, United States
Completed
Oulu, 90020, Finland
Completed
Recklinghausen, 45659, Germany
Completed
Dresden, 01307, Germany
Completed
Cambridge, CB2 0QQ, United Kingdom
Completed
Milano, 20089, Italy
Completed
Uddevalla, 451 80, Sweden
Withdrawn
Clermont- Ferrand, 63000, France
Withdrawn
Limoges, 87042, France
Completed
Brescia, 25123, Italy
Withdrawn
Brugge, 8000, Belgium
Withdrawn
EDEGEM, 2650, Belgium
Withdrawn
GILLY, 6060, Belgium
Withdrawn
Cleveland, 44106, United States
Withdrawn
Pleasant Hill, 94523, United States
Withdrawn
Los Angeles, 90033, United States
Withdrawn
San Diego, 92123, United States
Withdrawn
Joliet, 60435, United States
Completed
Detroit, 48202, United States
Withdrawn
Orlando, 32806, United States
Withdrawn
Pittsburgh, 15232, United States
Withdrawn
Bethesda, 20817, United States
Withdrawn
Nashville, 37232, United States
Completed
Montreal, H1T 2M4, Canada
Withdrawn
Evansville, 47713, United States
Withdrawn
Metairie, 70006, United States
Withdrawn
Greenville, 29601, United States
Withdrawn
Brewer, 04412, United States
Completed
Seattle, 98101, United States
Completed
Aurora, 80012, United States
Completed
Birmingham, 35213, United States
Completed
BREST, 29285, France
Completed
VANDOEUVRE-LES-NANCY, 54500, France
Withdrawn
Billings, 59107-7000, United States
Withdrawn
Sioux City, 51101, United States
Completed
Madrid, 28050, Spain
Completed
WILRIJK, 2610, Belgium
Completed
Potsdam, 14467, Germany
Completed
Anaheim, 90801, United States
Withdrawn
Lansing, 48912, United States
Completed
Ramat Gan, 5262000, Israel
Completed
Petach Tikva, 4941492, Israel
Withdrawn
Tel Aviv, 6423906, Israel
Withdrawn
Beer Sheva, 8410101, Israel
Completed
Ankara, 06100, Turkey
Withdrawn
Ankara, 6560, Turkey
Completed
Izmir, 35100, Turkey
Completed
Istanbul, 34093, Turkey
Withdrawn
Boca Raton, 33486, United States
Completed
Garran, 2605, Australia
Withdrawn
Boston, 02215, United States
Withdrawn
Miami Gardens, 33169, United States
Completed
Birmingham, B9 5SS, United Kingdom
Completed
Harrow, HA1 3UJ, United Kingdom
Completed
Romford, RM7 0AG, United Kingdom
Withdrawn
Wroclaw, 50-367, Poland
Completed
Nizhny Novgorod, 603126, Russian Federation
Withdrawn
Moscow, 115478, Russian Federation
Completed
Moscow, 129128, Russian Federation
Withdrawn
Samara, 443095, Russian Federation
Completed
St. Petersburg, 197101, Russian Federation
Completed
Seoul, 3080, Korea, Republic Of
Completed
Seoul, 6351, Korea, Republic Of
Completed
Busan, 49201, Korea, Republic Of
Completed
Clinton, 2753, United States
Completed
Spokane, 99208-1129, United States
Withdrawn
Lublin, 20-081, Poland
Withdrawn
Alexandria, 71301, United States
Completed
Englewood, 80113, United States
Withdrawn
Kashiwa, 277-8577, Japan
Withdrawn
Chuo-ku, 104-0045, Japan
Withdrawn
Koto-ku, 135-8550, Japan
Withdrawn
Isehara, 259-1193, Japan
Withdrawn
Nagoya, 460-0001, Japan
Withdrawn
Nagoya, 466-8560, Japan
Withdrawn
Nagoya, 467-8602, Japan
Withdrawn
Fukuoka, 812-8582, Japan
Withdrawn
Springfield, 65807, United States
Completed
Gilbert, 85234, United States
Withdrawn
Columbia, 65212, United States
Completed
Fort Collins, 80528, United States
Withdrawn
Green Bay, 54311, United States
Withdrawn
Warszawa, 02-781, Poland
Completed
Christchurch, New Zealand
Withdrawn
Beijing, 100142, China
Withdrawn
Beijing, 100000, China
Withdrawn
Shanghai, 200000, China
Withdrawn
Guangzhou, 510000, China
Withdrawn
St. Petersburg, 197341, Russian Federation
Withdrawn
Charleston, 29425, United States
Completed
Saratov, 410053, Russian Federation
Withdrawn
Athens, 30607, United States
Withdrawn
Los Angeles, 90025, United States
Withdrawn
Southfield, 48075, United States
Completed
Louisville, 40207, United States
Withdrawn
SAINT-DENIS CEDEX, 97405, France
Withdrawn
Boston, 02114, United States
Withdrawn
New Brunswick, 08903-2681, United States
Withdrawn
NICE Cedex 2, 06189, France
Withdrawn
OTTIGNIES, 1340, Belgium
Completed
TURNHOUT, 2300, Belgium
Completed
Tampere, 33521, Finland
Completed
Berlin, 10967, Germany
Withdrawn
Augsburg, 86150, Germany
Withdrawn
BAYONNE, 64100, France
Completed
Westbury, 11590, United States
Withdrawn
St. Petersburg, 197758, Russian Federation
Completed
Omsk, 644013, Russian Federation
Completed
Kemerovo, 650066, Russian Federation
Completed
Izmir, 35340, Turkey
Withdrawn
Innsbruck, 6020, Austria
Withdrawn
Linz, 4020, Austria
Completed
Linz, 4020, Austria
Completed
Singapore, 169608, Singapore
Completed
Singapore, 169610, Singapore
Completed
Hong Kong, NA, Hong Kong
Completed
Shatin, MISSING, Hong Kong
Completed
Münster, 48149, Germany
Completed
Lisboa, 1093 CODEX, Portugal
Withdrawn
Kfar Saba, 4428164, Israel
Completed
Budapest, 1083, Hungary
Completed
Zerifin, 7030000, Israel
Withdrawn
Copenhagen, 2100, Denmark
Withdrawn
Odense C, 5000, Denmark
Withdrawn
Aarhus C, 8000, Denmark
Withdrawn
Aalborg, 9100, Denmark
Completed
Kaposvar, 7400, Hungary
Completed
Budapest, 1097, Hungary
Withdrawn
Falun, 791 82, Sweden
Completed
POITIERS, 86021, France
Withdrawn
Angers, 49933, France
Withdrawn
TOURS, 37044, France
Withdrawn
Sofia, 1233, Bulgaria
Completed
Sofia, 1431, Bulgaria
Withdrawn
Vratsa, 3000, Bulgaria
Withdrawn
Egg Harbor Township, 08234, United States
Completed
LA ROCHE SUR YON, 85925, France
Withdrawn
Encinitas, 92024, United States
Completed
Canton, 44718, United States
Withdrawn
Salt Lake City, 84106, United States
Withdrawn
Anchorage, 99503, United States
Withdrawn
LUXEMBOURG, 1210, Luxembourg
Withdrawn
Esch-sur-Alzette, 4220, Luxembourg
Withdrawn
Fresno, 93720, United States
Withdrawn
Dublin, D07 R2WY, Ireland
Withdrawn
Dublin, D08 NHY1, Ireland
Completed
Galway, H91 YR71, Ireland
Completed
Gdynia, 81-519, Poland
Completed
Krakow, 30-510, Poland
Completed
Athens, 11526, Greece
Withdrawn
Chaidari, 12462, Greece
Withdrawn
Athens, 106 76, Greece
Withdrawn
Thessaloniki, 57010, Greece
Withdrawn
Graz, 8036, Austria
Withdrawn
Charleston, 29414, United States
Withdrawn
Temuco, 4810469, Chile
Withdrawn
Tulsa, 74133, United States
Withdrawn
Montería, 230002, Colombia
Withdrawn
Medellin, 050010, Colombia
Withdrawn
Florida Blanca, 681004, Colombia
Withdrawn
Lima, LIMA 11, Peru
Withdrawn
Lima, LIMA 34, Peru
Withdrawn
Monterrey, 64460, Mexico
Withdrawn
Oaxaca, 68000, Mexico
Withdrawn
Kogarah, 2217, Australia
Withdrawn
Kingswood, 2747, Australia
Withdrawn
Waratah, 2298, Australia
Completed
Bologna, 40138, Italy
Completed
Torino, 10126, Italy
Completed
Roma, 00161, Italy
Completed
Napoli, 80131, Italy
Completed
Manchester, M20 4BX, United Kingdom
Completed
LILLE, 59037, France
Completed
Pierre Benite, 69495, France
Completed
Creteil, 94010, France
Completed
Majadahonda, 28222, Spain
Completed
Barcelona, 08036, Spain
Completed
Valencia, 46026, Spain
Completed
Sevilla, 41071, Spain
Completed
Marbella, 29603, Spain
Completed
Bruxelles, 1070, Belgium
Withdrawn
ANTWERPEN, 2020, Belgium
Completed
GENT, 9000, Belgium
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
LEUVEN, 3000, Belgium
Completed
San Antonio, 78229, United States
Completed
Sutton, SM2 5PT, United Kingdom
Completed
Leeds, LS9 7TF, United Kingdom
Completed
PESSAC, 33600, France
Completed
München, 81377, Germany
Completed
Berlin, 13353, Germany
Completed
Mainz, 55131, Germany
Withdrawn
Homburg, 66424, Germany
Completed
Southampton, SO16 6YD, United Kingdom
Completed
Liverpool, L7 8XP, United Kingdom
Completed
Plymouth, PL6 8DH, United Kingdom
Completed
PARIS cedex, 75475, France
Completed
Helsinki, 00290, Finland
Completed
Turku, FIN-20521, Finland
Withdrawn
Jyväskylä, 40620, Finland
Completed
Rouen, 76038, France
Completed
Saint John, E2L 4L2, Canada
Completed
Montreal, H3T 1E2, Canada
Completed
St. Louis Park, 55426, United States
Withdrawn
Lake Success, 11042, United States
Withdrawn
Morristown, 07962-1089, United States
Withdrawn
Westwood, 66205, United States
Completed
Oulu, 90020, Finland
Completed
Recklinghausen, 45659, Germany
Completed
Dresden, 01307, Germany
Completed
Cambridge, CB2 0QQ, United Kingdom
Completed
Milano, 20089, Italy
Completed
Uddevalla, 451 80, Sweden
Withdrawn
Clermont- Ferrand, 63000, France
Withdrawn
Limoges, 87042, France
Completed
Brescia, 25123, Italy
Withdrawn
Brugge, 8000, Belgium
Withdrawn
EDEGEM, 2650, Belgium
Withdrawn
CHARLEROI, 6000, Belgium
Withdrawn
Cleveland, 44106, United States
Withdrawn
Pleasant Hill, 94523, United States
Withdrawn
Los Angeles, 90033, United States
Withdrawn
San Diego, 92123, United States
Withdrawn
Joliet, 60435, United States
Completed
Detroit, 48202, United States
Withdrawn
Orlando, 32806, United States
Withdrawn
Pittsburgh, 15232, United States
Withdrawn
Bethesda, 20817, United States
Withdrawn
Nashville, 37232, United States
Completed
Montreal, H1T 2M4, Canada
Withdrawn
Evansville, 47713, United States
Withdrawn
Metairie, 70006, United States
Withdrawn
Greenville, 29601, United States
Withdrawn
Brewer, 04412, United States
Completed
Seattle, 98101, United States
Completed
Aurora, 80012, United States
Completed
Birmingham, 35213, United States
Completed
BREST, 29285, France
Completed
VANDOEUVRE-LES-NANCY, 54500, France
Withdrawn
Billings, 59107-7000, United States
Withdrawn
Sioux City, 51101, United States
Completed
Madrid, 28050, Spain
Completed
WILRIJK, 2610, Belgium
Completed
Potsdam, 14467, Germany
Completed
Anaheim, 90801, United States
Withdrawn
Lansing, 48912, United States
Completed
Ramat Gan, 5262000, Israel
Completed
Petach Tikva, 4941492, Israel
Withdrawn
Tel Aviv, 6423906, Israel
Withdrawn
Beer Sheva, 8410101, Israel
Completed
Ankara, 06100, Turkey
Withdrawn
Ankara, 6560, Turkey
Completed
Izmir, 35100, Turkey
Completed
Istanbul, 34093, Turkey
Withdrawn
Boca Raton, 33486, United States
Completed
Garran, 2605, Australia
Withdrawn
Boston, 02215, United States
Withdrawn
Miami Gardens, 33169, United States
Completed
Birmingham, B9 5SS, United Kingdom
Completed
Harrow, HA1 3UJ, United Kingdom
Completed
Romford, RM7 0AG, United Kingdom
Withdrawn
Wroclaw, 50-367, Poland
Completed
Nizhny Novgorod, 603126, Russian Federation
Withdrawn
Moscow, 115478, Russian Federation
Completed
Moscow, 129128, Russian Federation
Withdrawn
Samara, 443095, Russian Federation
Completed
St. Petersburg, 197101, Russian Federation
Completed
Seoul, 3080, Korea, Republic Of
Completed
Seoul, 6351, Korea, Republic Of
Completed
Busan, 49201, Korea, Republic Of
Completed
Clinton, 2753, United States
Completed
Spokane, 99208-1129, United States
Withdrawn
Lublin, 20-081, Poland
Withdrawn
Alexandria, 71301, United States
Completed
Englewood, 80113, United States
Withdrawn
Kashiwa, 277-8577, Japan
Withdrawn
Chuo-ku, 104-0045, Japan
Withdrawn
Koto-ku, 135-8550, Japan
Withdrawn
Isehara, 259-1193, Japan
Withdrawn
Nagoya, 460-0001, Japan
Withdrawn
Nagoya, 466-8560, Japan
Withdrawn
Nagoya, 467-8602, Japan
Withdrawn
Fukuoka, 812-8582, Japan
Withdrawn
Springfield, 65807, United States
Completed
Gilbert, 85234, United States
Withdrawn
Columbia, 65212, United States
Completed
Fort Collins, 80528, United States
Withdrawn
Green Bay, 54311, United States
Withdrawn
Warszawa, 02-781, Poland
Completed
Christchurch, New Zealand
Withdrawn
Beijing, 100142, China
Withdrawn
Beijing, 100000, China
Withdrawn
Shanghai, 200000, China
Withdrawn
Guangzhou, 510000, China
Withdrawn
St. Petersburg, 197341, Russian Federation
Withdrawn
Charleston, 29425, United States
Completed
Saratov, 410053, Russian Federation
Withdrawn
Athens, 30607, United States
Withdrawn
Los Angeles, 90025, United States
Withdrawn
Southfield, 48075, United States
Completed
Louisville, 40207, United States
Withdrawn
SAINT-DENIS CEDEX, 97405, France
Withdrawn
Boston, 02114, United States
Withdrawn
New Brunswick, 08903-2681, United States
Withdrawn
NICE Cedex 2, 06189, France
Withdrawn
OTTIGNIES, 1340, Belgium
Completed
TURNHOUT, 2300, Belgium
Completed
Tampere, 33521, Finland
Completed
Berlin, 10967, Germany
Withdrawn
Augsburg, 86150, Germany
Withdrawn
BAYONNE, 64100, France
Completed
Westbury, 11590, United States
Withdrawn
St. Petersburg, 197758, Russian Federation
Completed
Omsk, 644013, Russian Federation
Completed
Kemerovo, 650066, Russian Federation
Completed
Izmir, 35340, Turkey
Withdrawn
Innsbruck, 6020, Austria
Withdrawn
Linz, 4020, Austria
Completed
Linz, 4020, Austria
Completed
Singapore, 169608, Singapore
Completed
Singapore, 169610, Singapore
Completed
Hong Kong, NA, Hong Kong
Completed
Shatin, MISSING, Hong Kong
Completed
Münster, 48149, Germany
Completed
Lisboa, 1099-023, Portugal
Withdrawn
Kfar Saba, 4428164, Israel
Completed
Budapest, 1083, Hungary
Completed
Zerifin, 7030000, Israel
Withdrawn
Copenhagen, 2100, Denmark
Withdrawn
Odense C, 5000, Denmark
Withdrawn
Aarhus C, 8000, Denmark
Withdrawn
Aalborg, 9100, Denmark
Completed
Kaposvar, 7400, Hungary
Completed
Budapest, 1097, Hungary
Withdrawn
Falun, 791 82, Sweden
Completed
POITIERS, 86021, France
Withdrawn
Angers, 49933, France
Withdrawn
TOURS, 37044, France
Withdrawn
Sofia, 1233, Bulgaria
Completed
Sofia, 1431, Bulgaria
Withdrawn
Vratsa, 3000, Bulgaria
Withdrawn
Egg Harbor Township, 08234, United States
Completed
LA ROCHE SUR YON, 85925, France
Withdrawn
Encinitas, 92024, United States
Completed
Canton, 44718, United States
Withdrawn
Salt Lake City, 84106, United States
Withdrawn
Anchorage, 99503, United States
Withdrawn
LUXEMBOURG, 1210, Luxembourg
Withdrawn
Esch-sur-Alzette, 4220, Luxembourg
Withdrawn
Fresno, 93720, United States
Withdrawn
Dublin, D07 R2WY, Ireland
Withdrawn
Dublin, D08 NHY1, Ireland
Completed
Galway, H91 YR71, Ireland
Completed
Gdynia, 81-519, Poland
Completed
Krakow, 30-510, Poland
Completed
Athens, 11526, Greece
Withdrawn
Chaidari, 12462, Greece
Withdrawn
Athens, 106 76, Greece
Withdrawn
Thessaloniki, 57010, Greece
Withdrawn
Graz, 8036, Austria
Withdrawn
Charleston, 29414, United States
Withdrawn
Temuco, 4810469, Chile
Withdrawn
Tulsa, 74133, United States
Withdrawn
Montería, 230002, Colombia
Withdrawn
Medellin, 050010, Colombia
Withdrawn
Florida Blanca, 681004, Colombia
Withdrawn
Lima, LIMA 11, Peru
Withdrawn
Lima, LIMA 34, Peru
Withdrawn
Monterrey, 64460, Mexico
Withdrawn
Oaxaca, 68000, Mexico
Withdrawn
Kogarah, 2217, Australia
Withdrawn
Kingswood, 2747, Australia
Withdrawn
Waratah, 2298, Australia

Primary Outcome

  • Objective Response Rate (ORR) Based on Independent Review-Part A
    Objective response rate was defined as the proportion of participants with a best response rating of complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999, as evaluated by the Independent Response Adjudication Committee (IRAC). For chronic lymphocytic leukemia (CLL) patients Hallek criteria (2008) were used and assessed by investigator.
    date_rangeTime Frame:
    Baseline up to the last patient has completed the 16 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • ORR Based on Independent Review-Part B
    Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.
    date_rangeTime Frame:
    Baseline up to the last patient has completed the 16 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • ORR Based on Investigator Assessment-Part A
    Objective response rate was defined as the proportion of participants with a best response rating of CR, CRu or PR, based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999. For CLL patients Hallek criteria (2008) were used and assessed by investigator.
    date_rangeTime Frame:
    Baseline up to the last patient has completed the 16 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • ORR Based on Investigator Assessment-Part B
    Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.
    date_rangeTime Frame:
    Baseline up to the last patient has completed the 16 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Duration of Response (DOR) Based on Independent Review-Part A
    Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as ‘caused by disease progression’ except deaths with the reason “other” or “AE not related to disease progression.
    date_rangeTime Frame:
    Baseline up to approximately 6 years
    enhanced_encryption
    Safety Issue:
    No
  • DOR Based on Independent Review-Part B
    Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as ‘caused by disease progression’ except deaths with the reason “other” or “AE not related to disease progression.
    date_rangeTime Frame:
    Baseline up to approximately 10 years
    enhanced_encryption
    Safety Issue:
    No
  • DOR Based on Investigator Assessment-Part A
    Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as ‘caused by disease progression’ except deaths with the reason “other” or “AE not related to disease progression.
    date_rangeTime Frame:
    Baseline up to approximately 6 years
    enhanced_encryption
    Safety Issue:
    No
  • DOR Based on Investigator Assessment-Part B
    Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as ‘caused by disease progression’ except deaths with the reason “other” or “AE not related to disease progression.
    date_rangeTime Frame:
    Baseline up to approximately 10 years
    enhanced_encryption
    Safety Issue:
    No
  • Progression Free Survival (PFS) Based on Independent Review-Part A
    PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
    date_rangeTime Frame:
    Baseline up to approximately 6 years
    enhanced_encryption
    Safety Issue:
    No
  • PFS Based on Independent Review-Part B
    PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
    date_rangeTime Frame:
    Baseline up to approximately 10 years
    enhanced_encryption
    Safety Issue:
    No
  • PFS Based on Investigator Assessment-Part A
    PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
    date_rangeTime Frame:
    Baseline up to approximately 6 years
    enhanced_encryption
    Safety Issue:
    No
  • PFS Based on Investigator Assessment-Part B
    PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).
    date_rangeTime Frame:
    Baseline up to approximately 10 years
    enhanced_encryption
    Safety Issue:
    No
  • Overall Survival (OS)-Part A
    OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause.
    date_rangeTime Frame:
    Baseline up to approximately 6 years
    enhanced_encryption
    Safety Issue:
    No
  • OS-Part B
    OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause.
    date_rangeTime Frame:
    Baseline up to approximately 10 years
    enhanced_encryption
    Safety Issue:
    No
  • Functional Assessment of Cancer Therapy – Lymphoma Lymphoma Subscale (FACT-Lym LymS) at Week 16 - Part B
    HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. Score range for the FACT-Lym LymS was 0 - 60, higher score represent less symptoms. Here in below table “n” signifies evaluable participants for the respective category.
    date_rangeTime Frame:
    Baseline up to week 16
    enhanced_encryption
    Safety Issue:
    No
  • Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym) total score at Week 16 - Part B
    HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. FACT-Lym total score range was 0-168, higher score indicates better HRQoL. Here, in the below table “n” signifies evaluable participants for the respective category.
    date_rangeTime Frame:
    Baseline up to week 16
    enhanced_encryption
    Safety Issue:
    No

Trial design

Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3