Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma

Stanford University

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma; Other Subtypes of B-cell Lymphoma; Mantle Cell Lymphoma; Lymphoma; Diffuse Large Cell Lymphoma; Transformed Lymphoma

Treatments: Drug: Rituximab 375 mg/m2

Study type: Interventional

Funder types: Other

Identifiers

NCT00225212

73750 (Other Identifier)

protocol97

Details and patient eligibility

About

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 transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.

Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.

Full 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 the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.

Enrollment: 35 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Rituximab after ASCT

Experimental group

Description:

Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT.

Treatment:

Drug: Rituximab 375 mg/m2