check_circleStudy Completed
Lymphoma, Non-Hodgkin
Bayer Identifier:
16349
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
BothAge
18 - N/ATrial summary
Enrollment Goal
227Trial Dates
November 2012 - May 2023Phase
Phase 2Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 AObjective 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 treatmentenhanced_encryptionNoSafety Issue:
- ORR Based on Independent Review-Part BObjective 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 treatmentenhanced_encryptionNoSafety Issue:
- ORR Based on Investigator Assessment-Part AObjective 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 treatmentenhanced_encryptionNoSafety Issue:
- ORR Based on Investigator Assessment-Part BObjective 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 treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Duration of Response (DOR) Based on Independent Review-Part ADuration 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 yearsenhanced_encryptionNoSafety Issue:
- DOR Based on Independent Review-Part BDuration 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 yearsenhanced_encryptionNoSafety Issue:
- DOR Based on Investigator Assessment-Part ADuration 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 yearsenhanced_encryptionNoSafety Issue:
- DOR Based on Investigator Assessment-Part BDuration 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 yearsenhanced_encryptionNoSafety Issue:
- Progression Free Survival (PFS) Based on Independent Review-Part APFS 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 yearsenhanced_encryptionNoSafety Issue:
- PFS Based on Independent Review-Part BPFS 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 yearsenhanced_encryptionNoSafety Issue:
- PFS Based on Investigator Assessment-Part APFS 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 yearsenhanced_encryptionNoSafety Issue:
- PFS Based on Investigator Assessment-Part BPFS 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 yearsenhanced_encryptionNoSafety Issue:
- Overall Survival (OS)-Part AOS 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 yearsenhanced_encryptionNoSafety Issue:
- OS-Part BOS 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 yearsenhanced_encryptionNoSafety Issue:
- Functional Assessment of Cancer Therapy – Lymphoma Lymphoma Subscale (FACT-Lym LymS) at Week 16 - Part BHRQoL 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 16enhanced_encryptionNoSafety Issue:
- Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym) total score at Week 16 - Part BHRQoL 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 16enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
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