Study Stopped
Company decided to terminate this study due to study did not meet the primary endpoint.
Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
CHRONOS-4
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)
2 other identifiers
interventional
551
35 countries
201
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2016
Longer than P75 for phase_3
201 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedStudy Start
First participant enrolled
January 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2023
CompletedResults Posted
Study results publicly available
December 11, 2024
CompletedDecember 11, 2024
November 1, 2024
7.7 years
November 3, 2015
September 8, 2024
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
SRI: Occurrence of Dose-limiting Toxicities (DLT)
Dose-limiting toxicity is defined as any of the following occurring during Cycle 1 at a given dose level and regarded by the investigator and/or the sponsor to be possibly, probably, or definitely related to copanlisib given in combination with R-B or R-CHOP. General: any grade 5 hematologic or non-hematologic toxicity or any delay of \>2 weeks of Cycle 2 due to study treatment-related toxicity; Non-hematologic DLT: any non-hematologic toxicity grade ≥ 3; Hematologic DLT: grade 4 absolute neutrophil count decrease lasting \>7 days, or grade 4 febrile neutropenia, or grade 4 platelet count decreased or grade 3 platelet count decreased with serious bleeding, or signs of serious bleeding and/or international normalized ratio (INR) increased or partial thromboplastin time (PTT) prolonged of grade 3.
At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOP
Phase 3: Progression-free Survival (PFS) by Independent Central Review
PFS is defined as the time from randomization to progressive disease (PD) or death from any cause (if no progression is documented).
Approximately 6 years 4 months
Secondary Outcomes (17)
SRI: Best Overall Response
Approximately 7 years 8 months
SRI: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
Approximately 4 years 10 months
Phase 3: Objective Tumor Response Rate (ORR)-Independent Central Review
Up to 6 years 4 months
Phase 3: ORR-Investigator Assessment
Up to 6 years 4 months
Phase 3: Duration of Tumor Response (DOR)-Independent Central Review
Approximately 6 years 4 months
- +12 more secondary outcomes
Study Arms (2)
Copanlisib + R-B or R-CHOP / Arm 1
EXPERIMENTALCombination 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)
Placebo + R-B or R-CHOP / Arm 2
PLACEBO COMPARATORCombination of placebo and R-B or R-CHOP (phase III only)
Interventions
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 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 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 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 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 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 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 is given as 100 mg tablets daily from Day 2 to Day 6 for patients assigned to R-CHOP
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (201)
Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.
Chandler, Arizona, 85224, United States
Brian J. LeBerthon, MD
West Covina, California, 91790, United States
SCL Health Research at St Joseph's Hospital Denver CO
Denver, Colorado, 80218, United States
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, 31792, United States
Memorial Sloan Kettering Cancer Center- Bergen
New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Oncology Consultants
Houston, Texas, 77024-2645, United States
Texas Oncology- McAllen
McAllen, Texas, 78503, United States
Calvary Mater Hospital Newcastle
Waratah, New South Wales, 2298, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Ashford Cancer Centre Research Pty Ltd
Kurralta Park, South Australia, 5037, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6961, Australia
Eastern Health Integrated Renal Service
Box Hill, 3128, Australia
Institut Jules Bordet/Jules Bordet Instituut
Brussels, 1070, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
CHU de Liège
Liège, 4000, Belgium
Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, 80810-050, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research Center
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Centro de Pesquisas Oncológicas
Florianópolis, Santa Catarina, 88034-000, Brazil
Faculdade de Ciencias Medicas-Universidade Estadual Campinas
Campinas, São Paulo, 130839 970, Brazil
Centro Multidisciplinar de Estudos Clínicos EPP - Ltda.
São Bernardo do Campo, São Paulo, 09715-090, Brazil
IEP São Lucas
São Paulo, São Paulo, 01234-030, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, 20231-050, Brazil
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, 05403-000, Brazil
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
São Paulo, 05651-901, Brazil
UMHAT Sveti Georgi
Plovdiv, 4000, Bulgaria
University Multiprofile Hosp. for Active Treat. Sveti Ivan
Sofia, 1431, Bulgaria
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
Sofia, 1756, Bulgaria
Multiprofile Hospital for Active Treatment Hristo Botev AD
Vratsa, 3000, Bulgaria
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, QC H4J 1C5, Canada
Hopital de L'Enfant Jesus
Québec, Quebec, G1J 1Z4, Canada
Centre Universitaire de Sante de l'Estrie
Sherbrooke, Quebec, J1H 5N4, Canada
Sociedad de Investigaciones Medicas Ltda
Temuco, Región de la Araucanía, 4810469, Chile
Centro de Investigaciones Clínicas Vina del Mar Ltda.
Viña del Mar, Región de Valparaíso, 2540364, Chile
Instituto Nacional del Cáncer
Santiago, 838-0455, Chile
FuJian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Tumor Hospital of Hebei Province
Hebei, Hebei, 050000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000, China
1st Affiliated hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The Affiliated Hospital of Qingdao University
Shandong, Shandong, 266000, China
West China Hospital Sichuan University
Chengdu, Sichuan, 610041, China
The 1st Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Fifth Medical Center, General Hospital of the Chinese People
Beijing, 100000, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
Fudan University Shanghai Cancer Center
Shanghai, 200000, China
Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine
Shanghai, 200092, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300000, China
Tianjin Union Medicine Centre (People's Hospital of Tianjin)
Tianjin, 300121, China
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 10034, Czechia
Rigshospitalet - Hjertesygdomme
København Ø, 2100, Denmark
Odense Universitetshospital - Hæmatologisk afdeling
Odense C, 5000, Denmark
HUS, Meilahden sairaala
Helsinki, FIN-00260, Finland
Oulun yliopistollinen sairaala
Oulu, 90220, Finland
Tampereen yliopistollinen sairaala
Tampere, 33520, Finland
Turun yliopistollinen keskussairaala
Turku, 20520, Finland
Centre Hospitalier Universitaire - Angers
Angers, 49933, France
Centre Hospitalier de la Durance - Avignon
Avignon, 84000, France
Centre Hospitalier Intercommunal de la Côte Basque-Bayonne
Bayonne, 64100, France
Centre Hospitalier Universite de Grenoble
Grenoble, 38043, France
Clinique Victor Hugo - Le Mans
Le Mans, 72015, France
Hôpital Dupuytren
Limoges, 87042, France
Hôpital Saint-Eloi
Montpellier, 34059, France
Hopital Hotel Dieu - Nantes
Nantes, 44000, France
Hôpital Saint Louis
Paris, 75010, France
Centre François Magendie - Pessac
Pessac, 33600, France
Hôpital de la Milétrie
Poitiers, 86021, France
Clinique Saint Anne
Strasbourg, 67000, France
Stauferklinikum Schwäbisch-Gmünd
Mutlangen, Baden-Wurttemberg, 73557, Germany
Haematologie-Onkologie im Zentrum MVZ GmbH
Augsburg, Bavaria, 86150, Germany
Klinikum der Universität München Grosshadern
München, Bavaria, 81377, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, 30625, Germany
Marienhospital Herne Universitätsklinik
Herne, North Rhine-Westphalia, 44625, Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, 48149, Germany
Oncologianova GmbH
Recklinghausen, North Rhine-Westphalia, 45659, Germany
Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, 6120, Germany
EVANGELISMOS General Hospital of Athens
Athens, 106 76, Greece
General Hospital of Athens LAIKO
Athens, 11527, Greece
University General Hospital of Athens "ATTIKON"
Chaïdári, 12462, Greece
Univ. General Hospital of Larissa
Larissa, 41110, Greece
University General Hospital of Patras
Pátrai, 26500, Greece
Prince of Wales Hospital
Hong Kong, MISSING, Hong Kong
Semmelweis University
Budapest, 1083, Hungary
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, 4400, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7623, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Cork University Hospital
Cork, T12DC4A, Ireland
Mater Misericordiae University Hospital
Dublin, D07R2WY, Ireland
Rambam Health Corporation
Haifa, 3109601, Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, 9112001, Israel
Chaim Sheba Medical Center
Ramat Gan, 5262000, Israel
Shamir Medical Center (Assaf Harofeh)
Ẕerifin, 7030000, Israel
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, 16132, Italy
Humanitas Mirasole S.p.A.
Milan, Lombardy, 20089, Italy
IRCCS Fondazione Policlinico San Matteo
Pavia, Lombardy, 27100, Italy
A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
Ancona, The Marches, 60126, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
JCHO Kyushu Hospital
Kitakyushu, Fukuoka, 806-8501, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Tenri Hospital
Tenri, Nara, 632-8552, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Aomori Prefectural Central Hospital
Aomori, 030-8553, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Hiroshima Red Cross & Atomic-bomb Survivors Hospital
Hiroshima, 730-8619, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Osaka Red Cross Hospital
Osaka, 543-8555, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Hospital General de México SS
México, D. F., Mexico City, 6726, Mexico
Centro de Investigación Clínica Chapultepec S.A. de C.V.
Morelia, Michoacán, 58260, Mexico
Hospital Universitario "José Eleuterio González"
Monterrey, Nuevo León, TBC, Mexico
Centro Especializado en Investigación Clínica S.C.
Boca del Río, Veracruz, 94290, Mexico
Centro de Atencion e Investigacion Clinica en Oncologia SCP
Mérida, Yucatán, 97134, Mexico
Szpital Morski im. PCK
Gdynia, 81-519, Poland
Pratia McM Kraków
Krakow, 30-727, Poland
Wojew. Szpital Specjalistyczny im. M. Kopernika
Lodz, 93-513, Poland
Centro Clinico Academico Braga | Braga, Portugal
Braga, 4710-243, Portugal
Centro Hospitalar Universitario do Porto
Porto, 4099-001, Portugal
IPO Porto
Porto, 4200-072, Portugal
Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center
Porto, 4434-502, Portugal
Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare
Baia Mare, 430031, Romania
Sc Onco Card Srl
Brasov, 500152, Romania
Spitalul Clinic Colentina
Bucharest, 20125, Romania
Fundeni Clinical Institute
Bucharest, 22328, Romania
Spitalul Clinic Coltea
Bucharest, 30171, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245, Romania
Kemerovo Regional Clinical Hospital
Kemerovo, 650066, Russia
Clinical Oncological Dispensary of Omsk Region
Omsk, 644013, Russia
Research Institute of Oncology
Rostov-on-Don, 344037, Russia
RSRI of Hematology and Transfusiology
Saint Petersburg, 191024, Russia
Oncology Dispensary #2
Sochi, 354057, Russia
Siberian State Medical University
Tomsk, 634050, Russia
Republican Clinical Oncology Dispensary
Ufa, 450054, Russia
National University Hospital
Singapore, 119074, Singapore
National Cancer Center Singapore
Singapore, 168583, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
Outeniqua Cancercare Oncology Unit
George, Eastern Cape, 6530, South Africa
Cancercare Langenhoven
Port Elizabeth, Eastern Cape, 6045, South Africa
Albert Alberts Stem Cell Transplant Research Centre
Pretoria, Gauteng, 44, South Africa
Constantiaberg Medi Clinic
Cape Town, Western Cape, 7800, South Africa
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Institut Català d'Oncologia Badalona
Badalona, Barcelona, 8916, Spain
Institut Català d'Oncologia Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Clinica Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Regional de Malaga | Oncologia
Málaga, Málaga, 29010, Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Changhua Christian Hospital
Changhua, 50006, Taiwan
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, 833, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Siriraj Hospital, Mahidol
Bangkok, 10700, Thailand
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, 6100, Turkey (Türkiye)
Trakya Univ. Tip Fak.
Edirne, 22030, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093, Turkey (Türkiye)
Marmara Uni. Tip Fak. Pendik EAH Hematoloji BD
Istanbul, 34899, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 35100, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir, 35100, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, 38039, Turkey (Türkiye)
Ondokuz Mayis Uni Tip Fakultesi
Samsun, 55139, Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi
Trabzon, 61080, Turkey (Türkiye)
CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
Cherkasy, 18009, Ukraine
Municipal Non-Profit Enterprise "City Clinical Hospital ?4" of the Dnipro City Council
Dnipro, 49102, Ukraine
Clinic of National cancer institute - scientific and research department of pediatric oncology
Kyiv, 03022, Ukraine
State Institution - Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine
Lviv, 79044, Ukraine
CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council
Zaporizhzhya, 69600, Ukraine
Royal Devon & Exeter Hospital
Exeter, Devon, EX2 5DW, United Kingdom
Northwick Park Hospital
Harrow, London, HA1 3UJ, United Kingdom
St George's Hospital
Kogarah, London, 2217, United Kingdom
Dorset County Hospital
Dorchester, DT1 2JY, United Kingdom
Royal Marsden Hospital (London)
London, SW3 6JJ, United Kingdom
Singleton Hospital
Swansea, SA2 8QA, United Kingdom
Related Publications (2)
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.
PMID: 39058951DERIVEDMatasar 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.
PMID: 34389273DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer AG
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2015
First Posted
December 10, 2015
Study Start
January 6, 2016
Primary Completion
September 15, 2023
Study Completion
November 10, 2023
Last Updated
December 11, 2024
Results First Posted
December 11, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.