Clinical Trial Of C2b8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma
16 Years
65 Years
Both
Non-Hodgkin's Lymphoma
Trial Information
Clinical Trial Of C2b8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma
The first four patients will receive a single course of rituximab weekly x 4 weeks at the
standard dose of 375mg/m2 at 6 weeks from transplant. After an observation period to assess
acute and late toxicity, remaining cohort of patients will receive induction as above
followed by an additional 4 week course at 6 months post transplant. Accrual will be at a
rate not to exceed three patients/month.
Inclusion Criteria:
- B-cell, CD20+ NHL
- evidence of engraftment post ASCT
- performance status 0-1
- creatinine<2 mg/dl,bilirubin<2.0 mg/dl and LFTs <5 x ULN
Exclusion Criteria:
- Non-responders (PD and SD) to prior anti-CD20 therapy
- evidence of active pneumonitis or infection
- no concurrent prednisone or other systemic steroid medication
- Concomitant treatment with radiotherapy, chemotherapy or immunotherapy
- Nitrosourea therapy within six weeks of the first treatment with rituximab
- Presence of anti-murine antibody (HAMA) reactivity
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the safety of one and two four-week courses of C2B8 (rituximab) following high dose chemotherapy and purged peripheral blood progenitor cells for B-cell NHL
Authority:
United States: Food and Drug Administration
Study ID:
protocol97
NCT ID:
NCT00225212
Start Date:
November 1997
Completion Date:
Related Keywords:
- Non-Hodgkin's Lymphoma
- B-cell
- recurrent
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
Name | Location |
|---|---|
| Stanford University Medical Center | Stanford, California 94305-5408 |
