Conditions: Non-Hodgkin's Lymphoma Diffuse Large Cell Lymphoma Mantle Cell Lymphoma Transformed Lymphoma Other Subtypes of B-cell Lymphoma Lymphoma
Keywords: non-Hodgkin's lymphoma diffuse large cell lymphoma mantle cell lymphoma transformed lymphoma other subtypes of B cell lymphoma recurrent lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

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 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.

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

Arms:
arm 1: 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.

Interventions: intervention 1: Rituximab 375 mg/m2
Intervention descriptions: intervention 1: None

Protocol document: