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Trial record 1 of 2 for:    CHRONOS-3
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Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) (CHRONOS-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02367040
Recruitment Status : Recruiting
First Posted : February 20, 2015
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of this study is 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.

Condition or disease Intervention/treatment Phase
Lymphoma,Non-Hodgkin Drug: Copanlisib (BAY 80-6946) Drug: Placebo Drug: Rituximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Copanlisib in Combination With Rituximab in Patients With Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-3
Actual Study Start Date : August 3, 2015
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : August 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Copanlisib + Rituximab
Combination of the Copanlisib and rituximab
Drug: Copanlisib (BAY 80-6946)
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. Dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered before rituximab.

Drug: Rituximab
Rituximab dose 375 mg/m2 body surface weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day 1 of Cycles 3, 5, 7 and 9.The solution for IV infusions is obtained after reconstitution of a calculated concentration of 1 to 4 mg/ml rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/ml (0.9%) solution for injection or 5% D-Glucose in water.

Placebo Comparator: Placebo + Rituximab
Combination of Copanlisib placebo and rituximab
Drug: 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 on Days 1, 8 and 15 of each 28-day cycle. Placebo will be administered before rituximab.

Drug: Rituximab
Rituximab dose 375 mg/m2 body surface weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day 1 of Cycles 3, 5, 7 and 9.The solution for IV infusions is obtained after reconstitution of a calculated concentration of 1 to 4 mg/ml rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/ml (0.9%) solution for injection or 5% D-Glucose in water.




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 59 months ]
    Progression free survival is defined as the time (in days) from randomization to Disease Progression or death from any cause (if no progression documented).


Secondary Outcome Measures :
  1. Objective tumor response [ Time Frame: 59 months ]
    Proportion of responders with best response either complete or partial response.

  2. Duration of response (DOR) [ Time Frame: 59 months ]
    Duration of response will only be defined for patients with at least one Complete Response or Partial Response. Patients without disease progression or death at the time of analysis will be censored at the date of their last tumor evaluation.

  3. Complete response [ Time Frame: 59 months ]
    Assessed in all patients up to the time of analysis of Progression-free survival.

  4. Time to progression (TTP) [ Time Frame: 59 months ]
    The time from randomization to Disease progression or death related to Disease Progression.

  5. Overall survival (OS) [ Time Frame: 59 months ]
    The time (in days) from randomization until death from any cause.

  6. Time to deterioration in DRS-P of at least 3 points as measured by the FLymSI-18 (Lymphoma Symptom Index -18)questionnaire [ Time Frame: 59 months ]
  7. Number of participants with adverse Events as a measure of safety and tolerability [ Time Frame: 59 months ]
  8. Time to improvement in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, will be evaluated for patients with a baseline DRS-P score of 30 points or less [ Time Frame: 59 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 last rituximab-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); 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 (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 last rituximab-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-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 containing treatment (including rituximab maintenance). For patients considered unwilling/unfit to receive chemotherapy : progression free interval or treatment free interval of less than 6 months since the last rituximab containing treatment (including rituximab maintenance), 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367040


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Hide Study Locations
Locations
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United States, Arkansas
Withdrawn
Little Rock, Arkansas, United States, 72205
Not yet recruiting
Rogers, Arkansas, United States, 72758
United States, California
Not yet recruiting
Bakersfield, California, United States, 93309
Not yet recruiting
Long Beach, California, United States, 90813
Not yet recruiting
West Covina, California, United States, 91790
Withdrawn
Whittier, California, United States, 90602
United States, Colorado
Not yet recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Not yet recruiting
Hartford, Connecticut, United States, 06106
United States, Florida
Not yet recruiting
Miami, Florida, United States, 33176
Not yet recruiting
Orange City, Florida, United States, 32763
United States, Illinois
Withdrawn
Maywood, Illinois, United States, 60153
United States, Kentucky
Recruiting
Ashland, Kentucky, United States, 41101
Recruiting
Louisville, Kentucky, United States, 40207
United States, Michigan
Withdrawn
Farmington Hills, Michigan, United States, 48334
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Not yet recruiting
Basking Ridge, New Jersey, United States, 07920
Withdrawn
Englewood, New Jersey, United States, 07361
Not yet recruiting
Middletown, New Jersey, United States, 07748
Recruiting
Montvale, New Jersey, United States, 07645
Not yet recruiting
Morristown, New Jersey, United States, 07962-1956
MSK Basking Ridge Recruiting
New Jersey, New Jersey, United States
MSK Bergen Recruiting
New Jersey, New Jersey, United States
MSK Monmoth Recruiting
New Jersey, New Jersey, United States
United States, New York
Not yet recruiting
Commack, New York, United States, 11725
Not yet recruiting
Harrison, New York, United States, 10604
MSK Westchester Recruiting
Harrison, New York, United States
MSK Commack Recruiting
Long Island City, New York, United States
MSK Rockville Centre Recruiting
Long Island City, New York, United States
Recruiting
New York, New York, United States, 10065
Not yet recruiting
Uniondale, New York, United States, 11553
United States, North Carolina
Withdrawn
Goldsboro, North Carolina, United States, 27534
United States, Ohio
Recruiting
Canton, Ohio, United States, 44718
Withdrawn
Cleveland, Ohio, United States, 44106-2602
United States, Oregon
Withdrawn
Bend, Oregon, United States, 97701
United States, Pennsylvania
Not yet recruiting
Allentown, Pennsylvania, United States, 18103
Withdrawn
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
Withdrawn
Watertown, South Dakota, United States, 57201
United States, Utah
Recruiting
Salt Lake City, Utah, United States, 84106
United States, Washington
Not yet recruiting
Olympia, Washington, United States, 98506
Recruiting
Spokane, Washington, United States, 99208-1129
Argentina
Withdrawn
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1406FWY
Recruiting
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1431FWO
Not yet recruiting
Cordoba, Córdoba, Argentina, X5000JHQ
Withdrawn
Ciudad Auton. de Buenos Aires, Argentina, C1114AAN
Recruiting
Córdoba, Argentina, X5000AOQ
Australia, New South Wales
Withdrawn
Kingswood, New South Wales, Australia, 2747
Withdrawn
Kogarah, New South Wales, Australia, 2217
Withdrawn
Orange, New South Wales, Australia, 2800
Withdrawn
Waratah, New South Wales, Australia, 2298
Australia, Victoria
Recruiting
Ballarat, Victoria, Australia, 3350
Australia
Recruiting
Nedlands, Australia, 6009
Austria
Withdrawn
Linz, Oberösterreich, Austria, 4020
Completed
Graz, Steiermark, Austria, 8036
Withdrawn
Leoben, Steiermark, Austria, 8700
Landeskrankenhaus Rankweil Not yet recruiting
Rankweil, Vorarlberg, Austria, 6830
Withdrawn
Krems, Austria, 3500
Withdrawn
Linz, Austria, 4020
Withdrawn
Salzburg, Austria, 5020
Not yet recruiting
Wien, Austria, 1090
Recruiting
Wien, Austria, 1130
Belarus
Not yet recruiting
Lesnoy, Belarus, 223040
Not yet recruiting
Minsk, Belarus, 220013
Belgium
Not yet recruiting
Bruxelles - Brussel, Belgium, 1020
Recruiting
Ottignies, Belgium, 1340
Withdrawn
Turnhout, Belgium, 2300
Not yet recruiting
Verviers, Belgium, 4800
Brazil
Not yet recruiting
Ijuí, Rio Grande Do Sul, Brazil, 98700-000
Recruiting
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-260
Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
Completed
Barretos, Sao Paulo, Brazil, 14784-400
Recruiting
Jaú, Sao Paulo, Brazil, 17210-120
Recruiting
São Paulo, Sao Paulo, Brazil, 01236-030
Recruiting
São Paulo, Sao Paulo, Brazil, 08270-070
Not yet recruiting
Brazil, Brazil
Withdrawn
Rio de Janeiro, Brazil, 22793-080
Recruiting
Sao Paulo, Brazil, 05651-901
Bulgaria
Recruiting
Plovdiv, Bulgaria, 4002
Terminated
Plovdiv, Bulgaria, 4002
Recruiting
Sofia, Bulgaria, 1756
Recruiting
Varna, Bulgaria, 9010
Chile
Recruiting
Temuco, Araucanía, Chile, 4810469
Withdrawn
Santiago, Chile, 8380456
Not yet recruiting
Santiago, Chile
China, Anhui
Withdrawn
Hefei, Anhui, China, 230001
China, Fujian
Recruiting
Fuzhou, Fujian, China, 350001
China, Guangdong
Recruiting
Guangzhou, Guangdong, China, 510060
Recruiting
Guangzhou, Guangdong, China, 510260
Not yet recruiting
Guangzhou, Guangdong, China, 510405
China, Henan
Withdrawn
Zhengzhou, Henan, China, 450052
China, Hubei
Not yet recruiting
Wuhan, Hubei, China, 430022
Recruiting
Wuhan, Hubei, China, 430079
China, Jiangsu
Recruiting
Nanjing, Jiangsu, China, 210009
Not yet recruiting
Nanjing, Jiangsu, China, 210009
Recruiting
Suzhou, Jiangsu, China, 215006
China, Jiangxi
Completed
Nanchang, Jiangxi, China, 330029
China, Jilin
Recruiting
Changchun, Jilin, China
China, Liaoning
Recruiting
Shengyang, Liaoning, China, 110042
China, Sichuan
Recruiting
Chengdu, Sichuan, China, 610041
China, Xinjiang
Not yet recruiting
Urumchi, Xinjiang, China
Recruiting
Urumqi, Xinjiang, China, 830011
China, Zhejiang
Recruiting
Hangzhou, Zhejiang, China, 310003
Recruiting
Hangzhou, Zhejiang, China, 310022
China
Recruiting
Beijing, China, 100021
Not yet recruiting
Beijing, China, 100034
Recruiting
Beijing, China, 100050
Recruiting
Beijing, China, 100071
Recruiting
Beijing, China, 100083
Withdrawn
Beijing, China, 100142
Recruiting
Beijing, China, 100730
Not yet recruiting
China, China
Recruiting
Chongqing, China, 400030
Recruiting
Shanghai, China, 200025
Recruiting
Shanghai, China, 200030
Recruiting
Shanghai, China, 200032
Not yet recruiting
Tianjin, China, 300060
Recruiting
Tianjin, China, 300121
Recruiting
Tianjin, China
Colombia
Recruiting
Medellín, Antioquia, Colombia, 050034
Not yet recruiting
Barranquilla, Atlántico, Colombia
Recruiting
Bogotá, Cundinamarca, Colombia
Recruiting
Montería, Córdoba, Colombia, 230002
Not yet recruiting
Floridablanca, Santander, Colombia, 681004
Not yet recruiting
Cali, Valle Del Cauca, Colombia
Recruiting
Cali, Valle Del Cauca, Colombia
Withdrawn
Bogota, Colombia
Denmark
Withdrawn
Aalborg, Denmark, 9100
Withdrawn
Aarhus C, Denmark, 8000
Withdrawn
Copenhagen, Denmark, 2100
Withdrawn
Odense C, Denmark, 5000
Withdrawn
Roskilde, Denmark, DK-4000
France
Recruiting
Bayonne, France, 64100
Recruiting
Brest, France, 29470
Withdrawn
Limoges, France, 87042
Recruiting
Metz Cedex 03, France, 57085
Completed
Nantes, France, 44805
Recruiting
NICE Cedex 2, France, 06189
Withdrawn
Perigueux, France, 24019
Recruiting
Pessac, France, 33600
Recruiting
Poitiers, France, 86021
Withdrawn
Vandoeuvre-les-nancy, France, 54511
Germany
Not yet recruiting
Aschaffenburg, Bayern, Germany, 63739
Withdrawn
Landshut, Bayern, Germany, 84028
Recruiting
München, Bayern, Germany, 81377
Withdrawn
Potsdam, Berlin, Germany, 14467
Recruiting
Recklinghausen, Nordrhein-Westfalen, Germany, 45659
Recruiting
Halle, Sachsen-Anhalt, Germany, 06120
Withdrawn
Chemnitz, Sachsen, Germany, 09116
Recruiting
Dresden, Sachsen, Germany, 01307
Recruiting
Berlin, Germany, 10967
Not yet recruiting
Hamburg, Germany, 22081
Greece
Recruiting
Athens, Greece, 106 76
Recruiting
Athens, Greece, 115 26
Recruiting
Chaidari, Greece, 12462
Withdrawn
Larissa, Greece, 41100
Recruiting
Patras, Greece, 26500
Withdrawn
Piraeus, Greece, 18 537
Withdrawn
Thessaloniki, Greece, 57010
Hong Kong
Recruiting
Chai wan, Hong Kong
Recruiting
Hong Kong, Hong Kong
Not yet recruiting
Kowloon, Hong Kong
Not yet recruiting
New Territories, Hong Kong
Recruiting
Shatin, Hong Kong
Hungary
Recruiting
Budapest, Hungary, 1083
Withdrawn
Budapest, Hungary, 1122
Recruiting
Gyor, Hungary, 9023
Recruiting
Kaposvar, Hungary, 7400
Recruiting
Pecs, Hungary, 7624
Recruiting
Tatabanya, Hungary, 2800
Ireland
Withdrawn
Dublin 4, Ireland
Recruiting
Dublin, Ireland, 7
Withdrawn
Dublin, Ireland, 9
Recruiting
Dublin, Ireland
Recruiting
Galway, Ireland
Italy
Not yet recruiting
Bologna, Emilia-Romagna, Italy, 40138
Withdrawn
Pordenone, Friuli-Venezia Giulia, Italy, 33081
Completed
Udine, Friuli-Venezia Giulia, Italy, 33100
Completed
Genova, Liguria, Italy, 16132
Withdrawn
Bergamo, Lombardia, Italy, 24127
Withdrawn
Milano, Lombardia, Italy, 20089
Recruiting
Milano, Lombardia, Italy, 20133
Withdrawn
Cagliari, Sardegna, Italy, 09121
Recruiting
Firenze, Toscana, Italy, 50141
Japan
Not yet recruiting
Nagoya, Aichi, Japan, 460-0001
Recruiting
Nagoya, Aichi, Japan, 464-8681
Recruiting
Nagoya, Aichi, Japan, 466-8650
Recruiting
Maebashi, Gunma, Japan, 371-8511
Recruiting
Kobe, Hyogo, Japan, 650-0047
Recruiting
Nankoku, Kochi, Japan, 783-8505
Recruiting
Sendai, Miyagi, Japan, 980-8574
Withdrawn
Matsumoto, Nagano, Japan, 390-8621
Recruiting
Omura, Nagasaki, Japan, 856-8562
Recruiting
Kurashiki, Okayama, Japan, 710-8602
Recruiting
Hirakata, Osaka, Japan, 573-1191
Recruiting
Izumo, Shimane, Japan, 693-8501
Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Not yet recruiting
Shinagawa-ku, Tokyo, Japan, 141-8625
Recruiting
Aomori, Japan, 030-8553
Recruiting
Fukuoka, Japan, 811-1395
Recruiting
Kumamoto, Japan, 860-8556
Recruiting
Niigata, Japan, 951-8566
Not yet recruiting
Okayama, Japan, 700-8558
Recruiting
Osaka, Japan, 545-8586
Recruiting
Yamagata, Japan, 990-9585
Korea, Republic of
Recruiting
Busan, Korea, Republic of, 49201
Recruiting
Busan, Korea, Republic of, 49241
Recruiting
Jeollanam-do, Korea, Republic of, 519-763
Recruiting
Seoul, Korea, Republic of, 03722
Recruiting
Seoul, Korea, Republic of, 06351
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Lithuania
Recruiting
Kaunas, Lithuania, LT-50009
Luxembourg
Withdrawn
Esch-sur-alzette, Luxembourg, 4220
Withdrawn
Luxembourg, Luxembourg, 1210
Malaysia
Recruiting
Ipoh, Malaysia
Not yet recruiting
Kelantan, Malaysia
Recruiting
Kota Kinabalu, Malaysia, 88200
Recruiting
Kuala Lumpur, Malaysia, 5600
Recruiting
Kuala Lumpur, Malaysia, 59100
Recruiting
Pulau Pinang, Malaysia
Recruiting
Selangor, Malaysia, 68000
Mexico
Withdrawn
México, D.F., Distrito Federal, Mexico, 06720
Recruiting
Morelia, Michoacán, Mexico, 58260
Withdrawn
Monterrey, Nuevo Leon, Mexico, 64000
Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Withdrawn
Oaxaca, Mexico, 68000
New Zealand
Recruiting
Tauranga, New Zealand, 3112
Philippines
Not yet recruiting
Cebu City, Philippines, 6000
Not yet recruiting
Manila, Philippines
Recruiting
Pasig City, Philippines
Recruiting
Quezon City, Philippines
Poland
Recruiting
Gdansk, Poland, 80-214
Recruiting
Gdynia, Poland, 81-519
Withdrawn
Gliwice, Poland, 44-101
Recruiting
Krakow, Poland, 30-510
Recruiting
Lublin, Poland, 20-090
Portugal
Withdrawn
Almada, Lisboa, Portugal, 2801-951
Recruiting
Vila Nova de Gaia, Porto, Portugal, 4434-502
Not yet recruiting
Porto, Portugal, 4099-001
Recruiting
Porto, Portugal, 4200-072
Not yet recruiting
Porto, Portugal, 4200-319
Romania
Not yet recruiting
Baia Mare, Romania, 430031
Recruiting
Brasov, Romania, 500152
Recruiting
Bucharest, Romania, 030171
Recruiting
Bucuresti, Romania, 010825
Not yet recruiting
Bucuresti, Romania, 020125
Recruiting
Bucuresti, Romania, 022328
Not yet recruiting
Cluj-Napoca, Romania, 400015
Recruiting
Craiova, Romania, 200143
Not yet recruiting
Iasi, Romania, 700111
Recruiting
Targu-Mures, Romania, 540136
Russian Federation
Recruiting
Chelyabinsk, Russian Federation, 454048
Withdrawn
Engels, Russian Federation, 413115
Recruiting
Irkutsk, Russian Federation, 664035
Recruiting
Kazan, Russian Federation, 420029
Recruiting
Kemerovo, Russian Federation, 650066
Recruiting
Kirov, Russian Federation, 610027
Withdrawn
Krasnoyarsk, Russian Federation, 660133
Not yet recruiting
Moscow, Russian Federation, 129128
Recruiting
Novosibirsk, Russian Federation, 630087
Recruiting
Omsk, Russian Federation, 644013
Not yet recruiting
Penza, Russian Federation, 440071
Recruiting
St. Petersburg, Russian Federation, 197022
Not yet recruiting
St. Petersburg, Russian Federation, 197758
Withdrawn
Tula, Russian Federation, 300053
Recruiting
Volgograd, Russian Federation, 400138
Singapore
Recruiting
Singapore, Singapore, 119228
Recruiting
Singapore, Singapore, 169608
Recruiting
Singapore, Singapore, 169610
Slovakia
Recruiting
Poprad, Slovakia, 085 01
South Africa
Recruiting
George, Eastern Cape, South Africa, 6530
Recruiting
Johannesburg, Gauteng, South Africa, 2013
Not yet recruiting
Pretoria, Gauteng, South Africa, 0044
Withdrawn
Pretoria, Gauteng, South Africa, 0140
Withdrawn
Pretoria, Gauteng, South Africa
Withdrawn
Saxonwold, Gauteng, South Africa, 2196
Spain
Not yet recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Recruiting
Majadahonda, Madrid, Spain, 28222
Recruiting
Barcelona, Spain, 08003
Completed
Barcelona, Spain, 08025
Recruiting
Barcelona, Spain, 08035
Recruiting
Madrid, Spain, 28041
Recruiting
Málaga, Spain, 29010
Completed
Salamanca, Spain, 37007
Sweden
Withdrawn
Falun, Sweden, 791 82
Withdrawn
Uddevalla, Sweden, 451 80
Taiwan
Recruiting
Changhua, Taiwan, 500
Recruiting
Kaohsiung, Taiwan, 833
Recruiting
Tainan, Taiwan
Recruiting
Taipei, Taiwan, 10002
Recruiting
Taipei, Taiwan, 11217
Thailand
Withdrawn
Bangkok, Thailand, 10330
Not yet recruiting
Bangkok, Thailand, 10400
Recruiting
Chiang Mai, Thailand, 50200
Not yet recruiting
Khon Kaen, Thailand, 40002
Recruiting
Pathumthani, Thailand, 10120
Turkey
Recruiting
Ankara, Turkey, 06100
Not yet recruiting
Ankara, Turkey, 06100
Recruiting
Istanbul, Turkey, 34093
Recruiting
Izmir, Turkey, 35100
Recruiting
Kayseri, Turkey, 38039
Recruiting
Trabzon, Turkey, 61080
Ukraine
Recruiting
Cherkasy, Ukraine, 18009
Recruiting
Dnipro, Ukraine, 49102
Withdrawn
Khmel'nytsky, Ukraine
Recruiting
Kiev, Ukraine, 03022
Recruiting
Lviv, Ukraine, 79044
Withdrawn
Uzhgorod, Ukraine, 88000
Recruiting
Vinnitsa, Ukraine, 21029
Not yet recruiting
Zaporizhzhya, Ukraine, 69600
Vietnam
Recruiting
Ha Noi, Vietnam
Recruiting
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02367040     History of Changes
Other Study ID Numbers: 17067
2013-003893-29 ( EudraCT Number )
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Clinical trial, Phase III
Phosphatidylinositol-3-kinase
Non-Hodgkin's lymphoma
Indolent B-cell non-Hodgkin's lymphoma

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents