- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01388959
A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma
November 1, 2016 updated by: Hoffmann-La Roche
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France, 31059
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Active viral hepatitis
- Eastern Cooperative Oncology Group (ECOG) performance status >2
- Patients not willing to sign informed consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm
|
375 mg/m2 intravenously once a week for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment response rate according to World Health Organization criteria (Group A)
Time Frame: Day 50
|
Day 50
|
Normalization of B-cell lymphoma 2 levels
Time Frame: Day 50
|
Day 50
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: 3 years
|
3 years
|
Safety: Incidence of adverse events
Time Frame: 3 years
|
3 years
|
Duration of treatment response
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1998
Primary Completion (Actual)
April 1, 2004
Study Completion (Actual)
April 1, 2004
Study Registration Dates
First Submitted
July 5, 2011
First Submitted That Met QC Criteria
July 5, 2011
First Posted (Estimate)
July 7, 2011
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- M39012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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