- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193440
Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma
Phase II Trial of Rituximab and Short Duration Chemotherapy Followed by Zevalin as First-Line Treatment for Patients With Low Grade Follicular Non-Hodgkin's Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Upon determination of eligibility, patients will be receive:
- Rituxan + CHOP or CVP + Ibritumomab Tiuxetan
Patients who are considered medical candidates for doxorubicin should receive CHOP chemotherapy (Cyclophosphamide, doxorubicin, vincristine and prednisone). Patients who are not considered medical candidates for doxorubicin should receive CVP chemotherapy (Cyclophosphamide, Vincristine, and prednisone)
Study Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
- Histologic documentation of follicular center, B-cell lymphoma
- Early stage lymphoma (stages I or II) relapsed after radiation therapy alone
- No previous chemotherapy or monoclonal antibody therapy
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
- Age > 18 years
- Adequate bone marrow ,liver and kidney function
- Must be accessible for treatment and follow-up.
- Bone marrow examination initial staging and accurate restaging
- All patients must give written informed consent prior to study entry.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
- Small lymphocytic (CLL type) lymphomas and CLL
- Impaired bone marrow reserve
- Female pregnant or lactating
- Serious active infection at the time of treatment
- Any other serious underlying condition
- Central nervous system involvement (brain or meningeal)
- HIV or AIDS-related lymphoma
- Received prior external beam radiation therapy to > 25% of active bone marrow
- Pleural effusion
- Received prior murine antibodies or proteins
- History of other neoplasms within five years of diagnosis
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall clinical response rate
|
Overall molecular response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Progression-free survival
|
Overall survival
|
Overall toxicity
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- SCRI LYM 22
- 106-PO69
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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