Clinical trial NCT02626455: Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lymphoma, Non-Hodgkin
Keywords: Clinical trial, Phase III
Phosphatidylinositol-3-kinase
Non-Hodgkin's lymphoma
Indolent B-cell non-Hodgkin's lymphoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-12-10
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Patients should be in need of and fit for immunochemotherapy and should not be resistant to rituximab (resistance defined as lack of response or progression within 6 months of the last date of rituximab administration, including rituximab, and/or rituximab biosimilars, and/or anti-CD20 monoclonal antibody).

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.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of B lymphocyte antigen CD20 positive iNHL with histological subtype limited to:

  * Follicular lymphoma G1-2-3a
  * Small lymphocytic lymphoma with absolute lymphocyte count \<5x10E9/L at study entry
  * Lymphoplasmacytoid lymphoma / Waldenström macroglobulinemia (LPL / WM)
  * Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
* Patients must have relapsed (recurrence after complete response or presented progression after partial response) or progressed after at least one but at most three prior lines of therapy, including rituximab, and/or rituximab biosimilars, and/or anti-CD20 monoclonal antibody (e.g. obinutuzumab) -based immunochemotherapy and alkylating agents (if given concomitantly is considered one line of therapy). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy with single agent rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody can be considered a previous regimen in the case the patient responded to it); at least 2 consecutive cycles of polychemotherapy; autologous transplant; or radioimmunotherapy. Previous exposure to other PI3K Inhibitors (except copanlisib) is acceptable provided there is no resistance (resistance defined as no response (response defined as partial response \[PR\] or complete response \[CR\]) at any time during therapy, or progressive disease (PD) after any response (PR/CR) or after stable disease within 6 months from the end of the therapy with a PI3K inhibitor.
* Non-WM patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL this requirement may be restricted to splenomegaly alone since that is usually the only manifestation of measurable disease.
* Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal and positive immunofixation test.
* Male or female patients ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Life expectancy of at least 3 months
* Availability of fresh tumor tissue and/or archival tumor tissue at Screening
* Adequate baseline laboratory values as assessed within 7 days before starting study treatment.
* Left ventricular ejection fraction ≥ 50%

Exclusion Criteria

* Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.
* Rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody (e.g. obinutuzumab) resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last date of rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody administration, including maintenance with these drugs).
* HbA1c \> 8.5% at screening
* History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator)
* Known lymphomatous involvement of the central nervous system
* Known history of human immunodeficiency virus (HIV) infection
* Hepatitis B (HBV) or hepatitis C (HCV) infection. Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy as per rituximab label. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
* Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.CMV PCR test is considered positive if, the result can be interpreted as a CMV viremia according to local standard of care.
* Uncontrolled hypertension despite optimal medical management (per investigator´s assessment)
* Congestive heart failure \> New York Heart Association (NYHA) class 2

Primary outcomes:
measure: SRI: Occurrence of Dose-limiting Toxicities (DLT)
timeFrame: At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOP
measure: Phase 3: Progression-free Survival (PFS) by Independent Central Review
timeFrame: Approximately 6 years 4 months
Secondary outcomes:
measure: SRI: Best Overall Response
timeFrame: Approximately 7 years 8 months
measure: SRI: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
timeFrame: Approximately 4 years 10 months
measure: Phase 3: Objective Tumor Response Rate (ORR)-Independent Central Review
timeFrame: Up to 6 years 4 months
measure: Phase 3: ORR-Investigator Assessment
timeFrame: Up to 6 years 4 months
measure: Phase 3: Duration of Tumor Response (DOR)-Independent Central Review
timeFrame: Approximately 6 years 4 months
measure: Phase 3: DOR-Investigator Assessment
timeFrame: Approximately 6 years 4 months
measure: Phase 3: Complete Tumor Response Rate (CRR)-Independent Central Review
timeFrame: Approximately 6 years 4 months
measure: Phase 3: CRR-Investigator Assessment
timeFrame: Approximately 6 years 4 months
measure: Phase 3: Disease Control Rate (DCR)-Independent Central Review
timeFrame: Approximately 6 years 4 months
measure: Phase 3: DCR-Investigator Assessment
timeFrame: Approximately 6 years 4 months
measure: Phase 3: Time to Tumor Progression (TTP)-Independent Central Review
timeFrame: Approximately 6 years 4 months
measure: Phase 3: TTP-Investigator Assessment
timeFrame: Approximately 6 years 4 months
measure: Phase 3: Time to Next Anti-lymphoma Treatment (TTNT)
timeFrame: Approximately 6 years 4 months
measure: Phase 3: Overall Survival (OS)
timeFrame: Approximately 6 years 4 months
measure: Phase 3: Time to Deterioration in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma
timeFrame: Approximately 6 years 4 months
measure: Phase 3: Time to Improvement in Disease-related Symptoms-physical (DRS-P) of at Least 3 Points of Lymphoma
timeFrame: Approximately 6 years 4 months
measure: Phase 3: Number of Subjects With Treatment-emergent Adverse Event (TEAE)
timeFrame: Approximately 4 years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.
state: Arizona
city: West Covina
country: United States
facility: Brian J. LeBerthon, MD
state: California
city: Denver
country: United States
facility: SCL Health Research at St Joseph's Hospital Denver CO
state: Colorado
city: Thomasville
country: United States
facility: Lewis Hall Singletary Oncology Center
state: Georgia
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center- Bergen
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Port Jefferson Station
country: United States
facility: New York Cancer and Blood Specialists
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: McAllen
country: United States
facility: Texas Oncology- McAllen
state: Texas
city: Waratah
country: Australia
facility: Calvary Mater Hospital Newcastle
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research Pty Ltd
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Box Hill
country: Australia
facility: Eastern Health Integrated Renal Service
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet/Jules Bordet Instituut
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: CHU de Liège
city: Curitiba
country: Brazil
facility: Centro Integrado de Oncologia de Curitiba
state: Parana
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research Center
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: Centro de Pesquisas Oncológicas
state: Santa Catarina
city: Campinas
country: Brazil
facility: Faculdade de Ciencias Medicas-Universidade Estadual Campinas
state: Sao Paulo
city: São Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clínicos EPP - Ltda.
state: Sao Paulo
city: São Paulo
country: Brazil
facility: IEP São Lucas
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi
city: Sofia
country: Bulgaria
facility: University Multiprofile Hosp. for Active Treat. Sveti Ivan
city: Sofia
country: Bulgaria
facility: SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD
city: Vratsa
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Hristo Botev AD
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Quebec City
country: Canada
facility: Hopital de L'Enfant Jesus
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Universitaire de Sante de l'Estrie
state: Quebec
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Ltda
state: Araucanía
city: Vina del Mar
country: Chile
facility: Centro de Investigaciones Clínicas Vina del Mar Ltda.
state: Valparaíso
city: Santiago
country: Chile
facility: Instituto Nacional del Cáncer
city: Fuzhou
country: China
facility: FuJian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Hebei
country: China
facility: Tumor Hospital of Hebei Province
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Suzhou
country: China
facility: 1st Affiliated hospital of Soochow University
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shandong
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The 1st Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Fifth Medical Center, General Hospital of the Chinese People
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Tianjin
country: China
facility: Tianjin Union Medicine Centre (People's Hospital of Tianjin)
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: København Ø
country: Denmark
facility: Rigshospitalet - Hjertesygdomme
city: Odense C
country: Denmark
facility: Odense Universitetshospital - Hæmatologisk afdeling
city: Helsinki
country: Finland
facility: HUS, Meilahden sairaala
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: Angers
country: France
facility: Centre Hospitalier Universitaire - Angers
city: Avignon
country: France
facility: Centre Hospitalier de la Durance - Avignon
city: Bayonne
country: France
facility: Centre Hospitalier Intercommunal de la Côte Basque-Bayonne
city: Grenoble
country: France
facility: Centre Hospitalier Universite de Grenoble
city: Le Mans Cedex 2
country: France
facility: Clinique Victor Hugo - Le Mans
city: Limoges Cedex
country: France
facility: Hôpital Dupuytren
city: Montpellier Cedex
country: France
facility: Hôpital Saint-Eloi
city: Nantes
country: France
facility: Hopital Hotel Dieu - Nantes
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pessac
country: France
facility: Centre François Magendie - Pessac
city: Poitiers
country: France
facility: Hôpital de la Milétrie
city: Strasbourg
country: France
facility: Clinique Saint Anne
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwäbisch-Gmünd
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Haematologie-Onkologie im Zentrum MVZ GmbH
state: Bayern
city: München
country: Germany
facility: Klinikum der Universität München Grosshadern
state: Bayern
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
state: Niedersachsen
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
state: Nordrhein-Westfalen
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Marienhospital Herne Universitätsklinik
state: NRW
city: Halle
country: Germany
facility: Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg
state: Sachsen-Anhalt
city: Athens
country: Greece
facility: EVANGELISMOS General Hospital of Athens
city: Athens
country: Greece
facility: General Hospital of Athens LAIKO
city: Chaidari
country: Greece
facility: University General Hospital of Athens "ATTIKON"
city: Larissa
country: Greece
facility: Univ. General Hospital of Larissa
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Kaposvar
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Tatabanya
country: Hungary
facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Haifa
country: Israel
facility: Rambam Health Corporation
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Hospital Ein Kerem
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Zerifin
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
state: Liguria
city: Milano
country: Italy
facility: Humanitas Mirasole S.p.A.
state: Lombardia
city: Pavia
country: Italy
facility: IRCCS Fondazione Policlinico San Matteo
state: Lombardia
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"
state: Marche
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Kitakyushu
country: Japan
facility: JCHO Kyushu Hospital
state: Fukuoka
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Tenri
country: Japan
facility: Tenri Hospital
state: Nara
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross & Atomic-bomb Survivors Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: México, D. F.
country: Mexico
facility: Hospital General de México SS
state: Distrito Federal
city: Morelia
country: Mexico
facility: Centro de Investigación Clínica Chapultepec S.A. de C.V.
state: Michoacán
city: Monterrey
country: Mexico
facility: Hospital Universitario "José Eleuterio González"
state: Nuevo Leon
city: Boca del Río
country: Mexico
facility: Centro Especializado en Investigación Clínica S.C.
state: Veracruz
city: Merida
country: Mexico
facility: Centro de Atencion e Investigacion Clinica en Oncologia SCP
state: Yucatán
city: Gdynia
country: Poland
facility: Szpital Morski im. PCK
city: Krakow
country: Poland
facility: Pratia McM Kraków
city: Lodz
country: Poland
facility: Wojew. Szpital Specjalistyczny im. M. Kopernika
city: Braga
country: Portugal
facility: Centro Clinico Academico Braga | Braga, Portugal
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto
city: Porto
country: Portugal
facility: IPO Porto
city: Porto
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center
city: Baia Mare
country: Romania
facility: Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare
city: Brasov
country: Romania
facility: Sc Onco Card Srl
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Fundeni Clinical Institute
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Craiova
country: Romania
facility: Spitalul Clinic Municipal Filantropia Craiova
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital
city: Omsk
country: Russian Federation
facility: Clinical Oncological Dispensary of Omsk Region
city: Rostov-on-Don
country: Russian Federation
facility: Research Institute of Oncology
city: Saint-Petersburg
country: Russian Federation
facility: RSRI of Hematology and Transfusiology
city: Sochi
country: Russian Federation
facility: Oncology Dispensary #2
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Center Singapore
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: George
country: South Africa
facility: Outeniqua Cancercare Oncology Unit
state: Eastern Cape
city: Port Elizabeth
country: South Africa
facility: Cancercare Langenhoven
state: Eastern Cape
city: Pretoria
country: South Africa
facility: Albert Alberts Stem Cell Transplant Research Centre
state: Gauteng
city: Cape Town
country: South Africa
facility: Constantiaberg Medi Clinic
state: Western Cape
city: Badalona
country: Spain
facility: Institut Català d'Oncologia Badalona
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Institut Català d'Oncologia Hospitalet
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Clinica Puerta de Hierro
state: Madrid
city: Malaga
country: Spain
facility: Hospital Regional de Malaga | Oncologia
state: Málaga
city: Barcelona
country: Spain
facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Kaohsiung
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi
city: Edirne
country: Turkey
facility: Trakya Univ. Tip Fak.
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi
city: Istanbul
country: Turkey
facility: Marmara Uni. Tip Fak. Pendik EAH Hematoloji BD
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Uni Tip Fakultesi
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Universitesi Tip Fakultesi
city: Cherkasy
country: Ukraine
facility: CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise "City Clinical Hospital ?4" of the Dnipro City Council
city: Kyiv
country: Ukraine
facility: Clinic of National cancer institute - scientific and research department of pediatric oncology
city: Lviv
country: Ukraine
facility: State Institution - Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine
city: Zaporizhzhya
country: Ukraine
facility: CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
state: Devon
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: London
city: Kogarah
country: United Kingdom
facility: St George's Hospital
state: London
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital (London)
city: Swansea
country: United Kingdom
facility: Singleton Hospital
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.