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.
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.
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There are 179 Locations for this study
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
New Jersey New Jersey, , United States
New Jersey New Jersey, , United States
New Jersey New Jersey, , United States
Harrison New York, , United States
Long Island City New York, , United States
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, CP: C, 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, 01234, 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, 48008, 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
Bogota 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 , 9024, 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 , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 3722, 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 , 30-72, Poland
Lublin , 20-09, Poland
Porto , 4200-, Portugal
Porto , 4434-, 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 , 08023, 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
Kyiv , 03022, Ukraine
Lviv , 79044, Ukraine
Vinnitsa , 21029, Ukraine
Ha Noi , 10000, Vietnam
Ho Chi Minh City , 70000, Vietnam
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