Status:
COMPLETED
Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Stanford University
Conditions:
Non-Hodgkin's Lymphoma
Diffuse Large Cell Lymphoma
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief Summary
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects. This study assesses autologous stem cell transpl...
Detailed Description
The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant. After an observation period to assess acute and late toxicity for...
Eligibility Criteria
Inclusion
- B-cell, CD20+ NHL
- Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Creatinine \< 2 mg/dL
- Bilirubin \< 2.0 mg/dL
- Liver function tests (LFTs) \< 5 x upper limit of normal (ULN)
Exclusion
- Graft source from bone marrow
- Non-responders \[progressive disease (PD) or stable disease (SD)\] to prior anti-CD20 therapy
- PD after ASCT
- Post-ASCT radiotherapy
- Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab
- Evidence of active pneumonitis
- Evidence of active infection
- Concurrent prednisone or other systemic steroid medication
- Nitrosourea therapy within 6 weeks of the first treatment with rituximab
- Presence of anti-murine antibody (HAMA) reactivity
Key Trial Info
Start Date :
November 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00225212
Start Date
November 1 1997
End Date
March 1 2003
Last Update
September 15 2014
Active Locations (1)
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1
Stanford University Medical Center
Stanford, California, United States, 94305