A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma
Multicentre, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab in Patients Suffering From Follicular Non-Hodgkin's Lymphoma (FNHL) With Residual Minimal Disease After Autologous Transplantation of hematopoïetic Stem Cell (Bone Marrow or Peripheral Blood)
1 other identifier
interventional
40
1 country
1
Brief Summary
This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.
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 Nov 1998
Longer than P75 for phase_2
1 active site
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
November 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 7, 2011
CompletedNovember 2, 2016
November 1, 2016
5.4 years
July 5, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment response rate according to World Health Organization criteria (Group A)
Day 50
Normalization of B-cell lymphoma 2 levels
Day 50
Secondary Outcomes (3)
Safety: Incidence of adverse events
3 years
Progression-free survival
3 years
Duration of treatment response
3 years
Study Arms (1)
Single arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, 18-75 years of age
- Diagnosis of follicular non-Hodgkin's lymphoma (FNHL)
- Previously treated with chemotherapy with autologous haemotopoietic stem cell transplantation (bone marrow or peripheral blood cells)
You may not qualify if:
- Active viral hepatitis
- Eastern Cooperative Oncology Group (ECOG) performance status \>2
- Patients not willing to sign informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Toulouse, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
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
July 5, 2011
First Posted
July 7, 2011
Study Start
November 1, 1998
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
November 2, 2016
Record last verified: 2016-11