Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
NCT ID: NCT02626455
Last Updated: 2024-12-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
551 participants
INTERVENTIONAL
2016-01-06
2023-11-10
Brief Summary
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Detailed Description
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This study will be composed of two parts: Safety run-in and phase III part. The purpose of the safety run-in part of this study is to assess whether the drug being tested (copanlisib) in combination with standard immunochemotherapy (R-B or R-CHOP) is safe and at what dose level of the study drug (copanlisib - 45mg or 60 mg) patients are able to tolerate the study treatment combination. In addition to finding a safe and tolerable dose level for the phase III part of the study, efficacy will also be evaluated for patients that stay on the study treatment during the safety run-in. The phase III part of the study started with the determined recommended dose of copanlisib of 60 mg in combination with R-B. Combination treatment of copanlisib at the recommended/approved dose of 60 mg with R-B or R-CHOP was completed in April 2021.
A maximum of 24 patients will take part in the safety run-in part of this study. In the phase III part approximately 520 patients will be randomly assigned to blinded treatment arms of copanlisib plus R-B or R-CHOP or placebo plus R-B or R-CHOP. Combination therapy (copanlisib/placebo with R-B or R-CHOP) will be administered for a maximum of 6 cycles (C1-C6). Copanlisib/placebo (study drug) monotherapy will be administered from C7 onwards.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Copanlisib + R-B or R-CHOP / Arm 1
Combination of copanlisib with standard immunochemotherapy (rituximab and bendamustine) \[R-B\] or rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone \[R-CHOP\] (safety run-in and phase III)
Copanlisib (BAY80-6946)
Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. For patients on R-B dosing of copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered and then rituximab followed by bendamustine. For patients on R-CHOP dosing of copanlisib will be administered on Days 1 and 8 of each 21-day cycle. Treatment with copanlisib/placebo will be continued up to 12 months.
Copanlisib will be administered before rituximab followed by cyclophosphamide, doxorubicin and vincristine infusions. Prednisone/prednisolone tablets to be taken for 5 days.
Rituximab
Rituximab is administered as an infusion at a dose of 375 mg/m2 body surface on Day 1 of each 28-day cycle for patients assigned to R-B and on Day 2 of each 21-day cycle for patients assigned to R-CHOP.
Cyclophosphamide
Cyclophosphamide is administered as an infusion at a dose of 750 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Doxorubicin
Doxorubicin is administered as an infusion at a dose of 50 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Vincristine
Vincristine is administered as an infusion at a dose of 1.4 mg/m2 body surface (maximum dose 2.0 mg) on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Bendamustine
Bendamustine is administered as an infusion at a dose of 90 mg/m2 body surface on Day 1 and Day 2 for patients assigned to R-B
Prednisone
Prednisone is given as 100 mg tablets daily from Day 2 to Day 6 for patients assigned to R-CHOP
Placebo + R-B or R-CHOP / Arm 2
Combination of placebo and R-B or R-CHOP (phase III only)
Placebo
Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered as per copanlisib described above. Applies to the phase III part of the study only.
Rituximab
Rituximab is administered as an infusion at a dose of 375 mg/m2 body surface on Day 1 of each 28-day cycle for patients assigned to R-B and on Day 2 of each 21-day cycle for patients assigned to R-CHOP.
Cyclophosphamide
Cyclophosphamide is administered as an infusion at a dose of 750 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Doxorubicin
Doxorubicin is administered as an infusion at a dose of 50 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Vincristine
Vincristine is administered as an infusion at a dose of 1.4 mg/m2 body surface (maximum dose 2.0 mg) on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Bendamustine
Bendamustine is administered as an infusion at a dose of 90 mg/m2 body surface on Day 1 and Day 2 for patients assigned to R-B
Prednisone
Prednisone is given as 100 mg tablets daily from Day 2 to Day 6 for patients assigned to R-CHOP
Interventions
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Copanlisib (BAY80-6946)
Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. For patients on R-B dosing of copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered and then rituximab followed by bendamustine. For patients on R-CHOP dosing of copanlisib will be administered on Days 1 and 8 of each 21-day cycle. Treatment with copanlisib/placebo will be continued up to 12 months.
Copanlisib will be administered before rituximab followed by cyclophosphamide, doxorubicin and vincristine infusions. Prednisone/prednisolone tablets to be taken for 5 days.
Placebo
Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered as per copanlisib described above. Applies to the phase III part of the study only.
Rituximab
Rituximab is administered as an infusion at a dose of 375 mg/m2 body surface on Day 1 of each 28-day cycle for patients assigned to R-B and on Day 2 of each 21-day cycle for patients assigned to R-CHOP.
Cyclophosphamide
Cyclophosphamide is administered as an infusion at a dose of 750 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Doxorubicin
Doxorubicin is administered as an infusion at a dose of 50 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Vincristine
Vincristine is administered as an infusion at a dose of 1.4 mg/m2 body surface (maximum dose 2.0 mg) on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Bendamustine
Bendamustine is administered as an infusion at a dose of 90 mg/m2 body surface on Day 1 and Day 2 for patients assigned to R-B
Prednisone
Prednisone is given as 100 mg tablets daily from Day 2 to Day 6 for patients assigned to R-CHOP
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.
Chandler, Arizona, United States
Brian J. LeBerthon, MD
West Covina, California, United States
SCL Health Research at St Joseph's Hospital Denver CO
Denver, Colorado, United States
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, United States
Memorial Sloan Kettering Cancer Center- Bergen
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Oncology Consultants
Houston, Texas, United States
Texas Oncology- McAllen
McAllen, Texas, United States
Calvary Mater Hospital Newcastle
Waratah, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Ashford Cancer Centre Research Pty Ltd
Kurralta Park, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Eastern Health Integrated Renal Service
Box Hill, , Australia
Institut Jules Bordet/Jules Bordet Instituut
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
CHU de Liège
Liège, , Belgium
Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research Center
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas Oncológicas
Florianópolis, Santa Catarina, Brazil
Faculdade de Ciencias Medicas-Universidade Estadual Campinas
Campinas, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos EPP - Ltda.
São Bernardo do Campo, São Paulo, Brazil
IEP São Lucas
São Paulo, São Paulo, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, , Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, , Brazil
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
São Paulo, , Brazil
UMHAT Sveti Georgi
Plovdiv, , Bulgaria
University Multiprofile Hosp. for Active Treat. Sveti Ivan
Sofia, , Bulgaria
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment Hristo Botev AD
Vratsa, , Bulgaria
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Hopital de L'Enfant Jesus
Québec, Quebec, Canada
Centre Universitaire de Sante de l'Estrie
Sherbrooke, Quebec, Canada
Sociedad de Investigaciones Medicas Ltda
Temuco, Región de la Araucanía, Chile
Centro de Investigaciones Clínicas Vina del Mar Ltda.
Viña del Mar, Región de Valparaíso, Chile
Instituto Nacional del Cáncer
Santiago, , Chile
FuJian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Tumor Hospital of Hebei Province
Hebei, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
1st Affiliated hospital of Soochow University
Suzhou, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The Affiliated Hospital of Qingdao University
Shandong, Shandong, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
The 1st Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Fifth Medical Center, General Hospital of the Chinese People
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine
Shanghai, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Tianjin Union Medicine Centre (People's Hospital of Tianjin)
Tianjin, , China
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Rigshospitalet - Hjertesygdomme
København Ø, , Denmark
Odense Universitetshospital - Hæmatologisk afdeling
Odense C, , Denmark
HUS, Meilahden sairaala
Helsinki, , Finland
Oulun yliopistollinen sairaala
Oulu, , Finland
Tampereen yliopistollinen sairaala
Tampere, , Finland
Turun yliopistollinen keskussairaala
Turku, , Finland
Centre Hospitalier Universitaire - Angers
Angers, , France
Centre Hospitalier de la Durance - Avignon
Avignon, , France
Centre Hospitalier Intercommunal de la Côte Basque-Bayonne
Bayonne, , France
Centre Hospitalier Universite de Grenoble
Grenoble, , France
Clinique Victor Hugo - Le Mans
Le Mans, , France
Hôpital Dupuytren
Limoges, , France
Hôpital Saint-Eloi
Montpellier, , France
Hopital Hotel Dieu - Nantes
Nantes, , France
Hôpital Saint Louis
Paris, , France
Centre François Magendie - Pessac
Pessac, , France
Hôpital de la Milétrie
Poitiers, , France
Clinique Saint Anne
Strasbourg, , France
Stauferklinikum Schwäbisch-Gmünd
Mutlangen, Baden-Wurttemberg, Germany
Haematologie-Onkologie im Zentrum MVZ GmbH
Augsburg, Bavaria, Germany
Klinikum der Universität München Grosshadern
München, Bavaria, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, Germany
Marienhospital Herne Universitätsklinik
Herne, North Rhine-Westphalia, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany
Oncologianova GmbH
Recklinghausen, North Rhine-Westphalia, Germany
Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, Germany
EVANGELISMOS General Hospital of Athens
Athens, , Greece
General Hospital of Athens LAIKO
Athens, , Greece
University General Hospital of Athens "ATTIKON"
Chaïdári, , Greece
Univ. General Hospital of Larissa
Larissa, , Greece
University General Hospital of Patras
Pátrai, , Greece
Prince of Wales Hospital
Hong Kong, , Hong Kong
Semmelweis University
Budapest, , Hungary
Orszagos Onkologiai Intezet
Budapest, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, , Hungary
Cork University Hospital
Cork, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
Rambam Health Corporation
Haifa, , Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Shamir Medical Center (Assaf Harofeh)
Ẕerifin, , Israel
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, Italy
Humanitas Mirasole S.p.A.
Milan, Lombardy, Italy
IRCCS Fondazione Policlinico San Matteo
Pavia, Lombardy, Italy
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
Ancona, The Marches, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
JCHO Kyushu Hospital
Kitakyushu, Fukuoka, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Tenri Hospital
Tenri, Nara, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Aomori Prefectural Central Hospital
Aomori, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Hiroshima Red Cross & Atomic-bomb Survivors Hospital
Hiroshima, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Osaka Red Cross Hospital
Osaka, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Yamagata University Hospital
Yamagata, , Japan
Hospital General de México SS
México, D. F., Mexico City, Mexico
Centro de Investigación Clínica Chapultepec S.A. de C.V.
Morelia, Michoacán, Mexico
Hospital Universitario "José Eleuterio González"
Monterrey, Nuevo León, Mexico
Centro Especializado en Investigación Clínica S.C.
Boca del Río, Veracruz, Mexico
Centro de Atencion e Investigacion Clinica en Oncologia SCP
Mérida, Yucatán, Mexico
Szpital Morski im. PCK
Gdynia, , Poland
Pratia McM Kraków
Krakow, , Poland
Wojew. Szpital Specjalistyczny im. M. Kopernika
Lodz, , Poland
Centro Clinico Academico Braga | Braga, Portugal
Braga, , Portugal
Centro Hospitalar Universitario do Porto
Porto, , Portugal
IPO Porto
Porto, , Portugal
Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center
Porto, , Portugal
Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare
Baia Mare, , Romania
Sc Onco Card Srl
Brasov, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Fundeni Clinical Institute
Bucharest, , Romania
Spitalul Clinic Coltea
Bucharest, , Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, , Romania
Kemerovo Regional Clinical Hospital
Kemerovo, , Russia
Clinical Oncological Dispensary of Omsk Region
Omsk, , Russia
Research Institute of Oncology
Rostov-on-Don, , Russia
RSRI of Hematology and Transfusiology
Saint Petersburg, , Russia
Oncology Dispensary #2
Sochi, , Russia
Siberian State Medical University
Tomsk, , Russia
Republican Clinical Oncology Dispensary
Ufa, , Russia
National University Hospital
Singapore, , Singapore
National Cancer Center Singapore
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Narodny onkologicky ustav
Bratislava, , Slovakia
Outeniqua Cancercare Oncology Unit
George, Eastern Cape, South Africa
Cancercare Langenhoven
Port Elizabeth, Eastern Cape, South Africa
Albert Alberts Stem Cell Transplant Research Centre
Pretoria, Gauteng, South Africa
Constantiaberg Medi Clinic
Cape Town, Western Cape, South Africa
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Institut Català d'Oncologia Badalona
Badalona, Barcelona, Spain
Institut Català d'Oncologia Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Clinica Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Regional de Malaga | Oncologia
Málaga, Málaga, Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Phramongkutklao Hospital
Bangkok, , Thailand
Siriraj Hospital, Mahidol
Bangkok, , Thailand
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Trakya Univ. Tip Fak.
Edirne, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Marmara Uni. Tip Fak. Pendik EAH Hematoloji BD
Istanbul, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, , Turkey (Türkiye)
Ondokuz Mayis Uni Tip Fakultesi
Samsun, , Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi
Trabzon, , Turkey (Türkiye)
CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
Cherkasy, , Ukraine
Municipal Non-Profit Enterprise "City Clinical Hospital ?4" of the Dnipro City Council
Dnipro, , Ukraine
Clinic of National cancer institute - scientific and research department of pediatric oncology
Kyiv, , Ukraine
State Institution - Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine
Lviv, , Ukraine
CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council
Zaporizhzhya, , Ukraine
Royal Devon & Exeter Hospital
Exeter, Devon, United Kingdom
Northwick Park Hospital
Harrow, London, United Kingdom
St George's Hospital
Kogarah, London, United Kingdom
Dorset County Hospital
Dorchester, , United Kingdom
Royal Marsden Hospital (London)
London, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Countries
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References
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Zinzani PL, Wang H, Feng J, Kim TM, Tao R, Zhang H, Fogliatto L, Maluquer Artigal C, Ozcan M, Yanez E, Kim WS, Kirtbaya D, Kriachok I, Maciel F, Xue H, Bouabdallah K, Phelps C, Chaturvedi S, Weispfenning A, Morcos PN, Odongo F, Buvaylo V, Childs BH, Dreyling M, Matasar M, Ghione P. CHRONOS-4: phase 3 study of copanlisib plus rituximab-based immunochemotherapy in relapsed indolent B-cell lymphoma. Blood Adv. 2024 Sep 24;8(18):4866-4876. doi: 10.1182/bloodadvances.2024013236.
Matasar MJ, Dreyling M, Leppa S, Santoro A, Pedersen M, Buvaylo V, Fletcher M, Childs BH, Zinzani PL. Feasibility of Combining the Phosphatidylinositol 3-Kinase Inhibitor Copanlisib With Rituximab-Based Immunochemotherapy in Patients With Relapsed Indolent B-cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):e886-e894. doi: 10.1016/j.clml.2021.06.021. Epub 2021 Jul 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2015-001088-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17833
Identifier Type: -
Identifier Source: org_study_id