Status:
TERMINATED
Study of Rituximab Plus High-Dose Chemotherapy Poor Prognosis Non-Hodgkin's Lymphoma
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Lymphoma, Non-Hodgkin's
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, stem cell support and Rituximab (which is a form of...
Detailed Description
Combination chemotherapy is the standard treatment as initial therapy for aggressive NHL. Standard chemotherapy cures less than 40% of patients. High-dose chemotherapy with stem cell support (or trans...
Eligibility Criteria
Inclusion
- Histologically documented, aggressive and/or intermediate grade and high-grade B cell NHL, CD20 positive.
- Histologic subtypes include follicular large cell, diffuse small cleaved cell, diffuse mixed small and large cell, diffuse large cell, anaplastic large cell, and mantle cell lymphomas.
- NHL must have high-intermediate or high International Prognostic Index (standard IPI) score at diagnosis. Mantle cell NHL is eligible regardless of IPI score.
- Complete or partial response to first-line therapy.
- Treated CNS or meningeal disease, using radiation therapy and/or intrathecal chemotherapy, is allowed. Patients with meningeal disease must have cytologically negative CSF at time of study entry.
- Cumulative total doxorubicin: \<500 mg/m2
- Performance score 0-2
- Patients with a prior malignancy are eligible if they were treated with curative intent and have no evidence of active disease.
- Patients must not be pregnant or nursing.
- Informed Consent
Exclusion
- pregnant or nursing
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00141700
Start Date
March 1 2003
End Date
December 1 2005
Last Update
January 10 2008
Active Locations (1)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109