Status:
COMPLETED
Study of Rituximab Plus High-Dose Chemotherapy 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, plus the addition of Rituximab (which is a form of ...
Detailed Description
Combination chemotherapy is the standard treatment as initial therapy for advanced stage aggressive Non-Hodgkin's lymphoma (NHL). Standard chemotherapy cures less than 40% of patients. When patients r...
Eligibility Criteria
Inclusion
- Histologically documented, aggressive and/ or intermediate grade and high-grade B cell NHL, CD20 positive.
- In relapse after primary conventional chemotherapy
- Tumor sensitive (at least a partial response) to induction chemotherapy and/ or radiation therapy after treatment for relapse
- Treatment of CNS or meningeal disease (cytology-negative CSF) if present
- Treatment of CNS or meningeal disease (cytology-negative CSF) if present.
- Cumulative total doxorubicin dosage \<500 mg/m2
- Performance score: 0-2
- Prior malignancies eligible if treated for cure and without active disease
- Patients must not be pregnant or nursing.
- Prior Immunotherapy is allowed
- Signed Informed Consent
- Absolute neutrophil count \> 1500/ µl, platelet count \>100,000/ µl
- Bilirubin \<1.5 x normal, SGOT \<2.5 x normal
- Serum creatinine \<1.5 mg/dl
- Ejection fraction \> 45% or \> 40% with normal wall motion
- HIV negative
- FEV1, DLCO \> 50% predicted
Exclusion
- Pregnant or nursing
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00143871
Start Date
April 1 2001
End Date
January 1 2007
Last Update
February 1 2012
Active Locations (1)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109