A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
Clinical Response in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma After Treatment With Anti-CD20 Antibody IDEC C2B8 (MabThera)
1 other identifier
interventional
38
1 country
11
Brief Summary
This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is \<3 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 1997
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 25, 2013
CompletedFirst Posted
Study publicly available on registry
December 2, 2013
CompletedResults Posted
Study results publicly available
November 4, 2014
CompletedDecember 3, 2014
October 1, 2014
11.1 years
November 25, 2013
October 30, 2014
November 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)
Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes \>1.500/ microliter (µL), hemoglobin (Hb) \>12 grams per deciliter (g/dL), and platelets \>100,000/µL. PR was defined as a less than (\<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Secondary Outcomes (6)
Number of Participants With a Clinical Response
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Time to Best Response
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Duration of Remission
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Time to Progression
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
Overall Survival (OS)
Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
- +1 more secondary outcomes
Study Arms (1)
MabThera/Rituxan
EXPERIMENTALInterventions
375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse
Eligibility Criteria
You may qualify if:
- adult patients \>= 18 years of age;
- centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
- relapse after chemotherapy (with or without interferon maintenance therapy).
You may not qualify if:
- primary refractory lymphomas;
- more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
- clinically significant cardiac disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Cologne, 50924, Germany
Unknown Facility
Erlangen, 91054, Germany
Unknown Facility
Göttingen, 37075, Germany
Unknown Facility
Grenzach-Wyhlen, 79639, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Homburg/saar, 66424, Germany
Unknown Facility
München, 80336, Germany
Unknown Facility
München, 81377, Germany
Unknown Facility
Münster, 48129, Germany
Unknown Facility
Stuttgart, 70376, Germany
Unknown Facility
Tübingen, 72076, 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 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2013
First Posted
December 2, 2013
Study Start
January 1, 1997
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
December 3, 2014
Results First Posted
November 4, 2014
Record last verified: 2014-10