A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
A Randomized, Open-label Study of the Effect of MabThera Plus Chemotherapy Versus Chemotherapy Alone on Clinical Response in Patients With Indolent Non-Hodgkin's and Mantle Cell Lymphoma
1 other identifier
interventional
360
1 country
33
Brief Summary
This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 1998
Longer than P75 for phase_3
33 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
Study Start
First participant enrolled
September 1, 1998
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
July 23, 2015
CompletedJuly 23, 2015
July 1, 2015
10.6 years
December 22, 2005
May 20, 2014
July 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving CR or PR at the End of Therapy
CR was defined as a complete remission of all objective medical findings at the time of restaging, with complete resolution of pre-existing swelling of the lymph nodes, as well as a pre-existing hepatomegaly and splenomegaly, for at least 4 weeks. This was in exclusion of persistent lymphoma infiltration of the bone marrow by means of bone marrow biopsy; normalization of blood counts with granulocytes greater than (\>)1.5 giga particles per liter (Gpt/L) (which is the equivalent of 10\^9/L), hemoglobin (Hb) \>7.5 millimoles per liter (mmol/L), and platelets less than (\<) 100 Gpt/L. PR was defined as greater than or equal to (≥)50 percent (%) reduction of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest perpendicular diameters) for at least 4 weeks without occurrence of new manifestations and normalization of blood counts.
Following completion of 6 cycles (24 weeks)
Secondary Outcomes (6)
Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months
24 months
Overall Survival (OS) - Percentage of Participants Alive at 24 Months
Month 24
Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months
Month 24
Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months
Month 24
Response Duration - Percentage of Participants Event Free at 24 Months
Month 24
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adult patients \>=18 years of age;
- advanced, low-grade non-Hodgkin's and mantle cell lymphoma.
You may not qualify if:
- possibility of curative radiation therapy;
- secondary NHL;
- participation in another clinical trial eg with cytostatic chemotherapy or cytokines;
- concomitant diseases and/or restricted organ function precluding therapy according to the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Berlin, 12203, Germany
Unknown Facility
Berlin, 13122, Germany
Unknown Facility
Bochum, 44791, Germany
Unknown Facility
Bonn, 53127, Germany
Unknown Facility
Borna, 04552, Germany
Unknown Facility
Chemnitz, 09113, Germany
Unknown Facility
Cottbus, 03046, Germany
Unknown Facility
Dresden, 01067, Germany
Unknown Facility
Dresden, 01307, Germany
Unknown Facility
Dülmen, 48249, Germany
Unknown Facility
Erfurt, 99089, Germany
Unknown Facility
Frankfurt (Oder), 15236, Germany
Unknown Facility
Greifswald, 17475, Germany
Unknown Facility
Güstrow, 18273, Germany
Unknown Facility
Halle, 06110, Germany
Unknown Facility
Halle, 06120, Germany
Unknown Facility
Jena, 07743, Germany
Unknown Facility
Jena, 07747, Germany
Unknown Facility
Leipzig, 04103, Germany
Unknown Facility
Leipzig, 04315, Germany
Unknown Facility
Magdeburg, 39120, Germany
Unknown Facility
Magdeburg, 39130, Germany
Unknown Facility
Marburg, 35043, Germany
Unknown Facility
Neubrandenburg, 17036, Germany
Unknown Facility
Nordhausen, 99734, Germany
Unknown Facility
Potsdam, 14467, Germany
Unknown Facility
Riesa, 01589, Germany
Unknown Facility
Rostock, 18055, Germany
Unknown Facility
Rostock, 18057, Germany
Unknown Facility
Schwerin, 19049, Germany
Unknown Facility
Stralsund, 18435, Germany
Unknown Facility
Trier, 54290, Germany
Unknown Facility
Zella-Mehlis, 98544, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 23, 2005
Study Start
September 1, 1998
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
July 23, 2015
Results First Posted
July 23, 2015
Record last verified: 2015-07