Non Hodgkin Lymphoma Clinical Trial

Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin’s Lymphoma (iNHL)

Summary

The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of Indolent non-Hodgkin's lymphoma (iNHL) in CD20 positive patients, with histological subtype limited to:

Follicular lymphoma(FL) grade1-2-3a
Small lymphocytic lymphoma(SLL) with absolute lymphocyte count <5x10*9/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) after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)-containing therapy (other previous treatment lines after rituximab are allowed). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy is allowed for patients who responded to single-agent rituximab, rituximab biosimilars, or anti-CD20 monoclonal antibody); at least 2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K is acceptable (except to copanlisib) provided there is no resistance. Patients with prior intolerance to PI3K inhibitors other than copanlisib are eligible.
Non-WM must have at least one bi-dimensionally measurable lesion (which has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL (Marginal-zone lymphoma) 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 (ULN) 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 for central pathology(obtained within 5 years of the consent date) at Screening
Adequate baseline laboratory values collected no more than 7 days before starting study treatment
Left ventricular ejection fraction ≥ 45%

Patients must either:

have had a progression-free and treatment-free interval of at least 12 months after completion of the rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment OR

be considered unfit to receive chemotherapy on reason of age, concomitant morbidities, and/or residual toxicity from previous treatments, or unwillingness to receive chemotherapy. These patients must also have had a progression-free and treatment-free interval of at least 6 months after completion of the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment. Patients in whom chemotherapy is contraindicated are defined by one of the following features:

Age ≥ 80 years

Age < 80 years and at least 1 of the following conditions:

at least 3 grade 3 CIRS-G comorbidities OR
at least 1 grade 4 CIRS-G comorbidity (if compatible to participation in the study).

Exclusion Criteria:

Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia
Progression free interval or treatment free interval of less than 12 months since the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)-containing treatment(including maintenance with these drugs). For patients considered unwilling/unfit to receive chemotherapy : progression free interval or treatment free interval of less than 6 months since the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment (including maintenance with these drugs), as assessed by the investigator
History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
Known lymphomatous involvement of the central nervous system
Patients with HbA1c > 8.5% at Screening
Known history of human immunodeficiency virus (HIV) infection
Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti- HCV antibody will be eligible if they are negative for HCV-RNA
Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors.
Prior treatment with copanlisib
Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

458

Study ID:

NCT02367040

Recruitment Status:

Active, not recruiting

Sponsor:

Bayer

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There are 179 Locations for this study

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West Covina California, 91790, United States

Ashland Kentucky, 41101, United States

Louisville Kentucky, 40207, United States

Bethesda Maryland, 20817, United States

Las Vegas Nevada, 89169, United States
MSK Basking Ridge
New Jersey New Jersey, , United States
MSK Bergen
New Jersey New Jersey, , United States
MSK Monmoth
New Jersey New Jersey, , United States
MSK Westchester
Harrison New York, , United States
MSK Commack
Long Island City New York, , United States
MSK Rockville Centre
Long Island City New York, , United States

New York New York, 10021, United States

New York New York, 10065, United States

Canton Ohio, 44718, United States

Salt Lake City Utah, 84106, United States

Spokane Washington, 99208, United States

Buenos Aires Ciudad Auton. De Buenos Aires, C1431, Argentina

Rosario Santa Fe, S2000, Argentina

San Miguel de Tucumán Tucuman, T4000, Argentina

Córdoba , X5000, Argentina

Ballarat Victoria, 3350, Australia

Nedlands , 6009, Australia

Graz Steiermark, 8036, Austria

Wien , 1090, Austria

Wien , 1130, Austria

Ottignies , 1340, Belgium

Passo Fundo Rio Grande Do Sul, 99020, Brazil

Porto Alegre Rio Grande Do Sul, 90880, Brazil

Barretos Sao Paulo, 14784, Brazil

Jaú Sao Paulo, 17210, Brazil

São Paulo Sao Paulo, 01236, Brazil

São Paulo Sao Paulo, 05403, Brazil

São Paulo Sao Paulo, 08270, Brazil

Sao Paulo , 05651, Brazil

Plovdiv , 4002, Bulgaria

Sofia , 1756, Bulgaria

Varna , 9010, Bulgaria

Temuco Araucanía, 48104, Chile

Fuzhou Fujian, 35000, China

Guangzhou Guangdong, 51006, China

Guangzhou Guangdong, 51026, China

Wuhan Hubei, 43007, China

Nanjing Jiangsu, 21000, China

Suzhou Jiangsu, 21500, China

Nanchang Jiangxi, 33002, China

Changchun Jilin, 13000, China

Shengyang Liaoning, 11004, China

Chengdu Sichuan, 61004, China

Urumqi Xinjiang, 83001, China

Hangzhou Zhejiang, 31000, China

Hangzhou Zhejiang, 31002, China

Beijing , 10002, China

Beijing , 10005, China

Beijing , 10007, China

Beijing , 10008, China

Beijing , 10073, China

Chongqing , 40003, China

Chongqing , 40004, China

Shanghai , 20002, China

Shanghai , 20003, China

Shanghai , 20003, China

Tianjin , 30000, China

Tianjin , 30012, China

Medellín Antioquia, 05003, Colombia

Bogotá Cundinamarca, 11151, Colombia

Montería Córdoba, 23000, Colombia

Cali Valle Del Cauca, 76003, Colombia

Bayonne , 64100, France

Brest , 29470, France

Metz Cedex 03 , 57085, France

Nantes , 44805, France

NICE Cedex 2 , 06189, France

Pessac , 33600, France

Poitiers , 86021, France

München Bayern, 81377, Germany

Recklinghausen Nordrhein-Westfalen, 45659, Germany

Halle Sachsen-Anhalt, 06120, Germany

Dresden Sachsen, 01307, Germany

Berlin , 10967, Germany

Athens , 106 7, Greece

Athens , 115 2, Greece

Chaidari , 12462, Greece

Patras , 26500, Greece

Chai Wan , , Hong Kong

Hong Kong , , Hong Kong

Shatin , , Hong Kong

Budapest , 1088, Hungary

Gyor , 9023, Hungary

Kaposvar , 7400, Hungary

Pecs , 7624, Hungary

Tatabanya , 2800, Hungary

Dublin , D07 R, Ireland

Dublin , D08 N, Ireland

Galway , H91 Y, Ireland

Udine Friuli-Venezia Giulia, 33100, Italy

Genova Liguria, 16132, Italy

Milano Lombardia, 20133, Italy

Firenze Toscana, 50141, Italy

Nagoya Aichi, 464-8, Japan

Nagoya Aichi, 466-8, Japan

Maebashi Gunma, 371-8, Japan

Kobe Hyogo, 650-0, Japan

Nankoku Kochi, 783-8, Japan

Sendai Miyagi, 980-8, Japan

Omura Nagasaki, 856-8, Japan

Kurashiki Okayama, 710-8, Japan

Hirakata Osaka, 573-1, Japan

Izumo Shimane, 693-8, Japan

Chuo-ku Tokyo, 104-0, Japan

Aomori , 030-8, Japan

Fukuoka , 811-1, Japan

Kumamoto , 860-8, Japan

Niigata , 951-8, Japan

Osaka , 545-8, Japan

Yamagata , 990-9, Japan

Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of

Busan , 49201, Korea, Republic of

Busan , 49241, Korea, Republic of

Jeollanam-do , 58128, Korea, Republic of

Seoul , 03722, Korea, Republic of

Seoul , 05505, Korea, Republic of

Seoul , 06351, Korea, Republic of

Kaunas , LT-50, Lithuania

Kota Kinabalu , 88586, Malaysia

Kuala Lumpur , 56000, Malaysia

Kuala Lumpur , 59100, Malaysia

Perak , 30450, Malaysia

Pulau Pinang , 10450, Malaysia

Selangor , 68000, Malaysia

Morelia Michoacán, 58260, Mexico

Monterrey Nuevo Leon, 64460, Mexico

Tauranga , 3112, New Zealand

Pasig City , 1600, Philippines

Quezon City , 1112, Philippines

Gdansk , 80-21, Poland

Gdynia , 81-51, Poland

Krakow , 30-51, Poland

Lublin , 20-09, Poland

Vila Nova de Gaia Porto, 4434-, Portugal

Porto , 4200-, Portugal

Brasov , 50015, Romania

Bucharest , 03017, Romania

Bucuresti , 01082, Romania

Bucuresti , 02012, Romania

Bucuresti , 02232, Romania

Cluj-Napoca , 40001, Romania

Craiova , 20014, Romania

Targu Mures , 54013, Romania

Chelyabinsk , 45404, Russian Federation

Irkutsk , 66403, Russian Federation

Kazan , 42002, Russian Federation

Kemerovo , 65006, Russian Federation

Kirov , 61002, Russian Federation

Novosibirsk , 63008, Russian Federation

Omsk , 64401, Russian Federation

St. Petersburg , 19702, Russian Federation

Volgograd , 40013, Russian Federation

Singapore , 11922, Singapore

Singapore , 16960, Singapore

Singapore , 16961, Singapore

Poprad , 085 0, Slovakia

George Eastern Cape, 6530, South Africa

Johannesburg Gauteng, 2013, South Africa

Majadahonda Madrid, 28222, Spain

Barcelona , 08003, Spain

Barcelona , 08035, Spain

Barcelona , 08041, Spain

Madrid , 28041, Spain

Málaga , 29010, Spain

Salamanca , 37007, Spain

Changhua , 50006, Taiwan

Kaohsiung , 833, Taiwan

Tainan , 704, Taiwan

Taipei , 100, Taiwan

Taipei , 11217, Taiwan

Chiang Mai , 50200, Thailand

Pathumthani , 10120, Thailand

Ankara , 06100, Turkey

Istanbul , 34093, Turkey

Izmir , 35100, Turkey

Kayseri , 38039, Turkey

Trabzon , 61080, Turkey

Cherkasy , 18009, Ukraine

Dnipro , 49102, Ukraine

Kiev , 03022, Ukraine

Lviv , 79044, Ukraine

Vinnitsa , 21029, Ukraine

Ha Noi , 10000, Vietnam

Ho Chi Minh City , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

458

Study ID:

NCT02367040

Recruitment Status:

Active, not recruiting

Sponsor:


Bayer

How clear is this clinincal trial information?

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