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Clinical Trial Of C2b8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma


Phase 2
16 Years
65 Years
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

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 CenterStanford, California  94305-5408