Phase 2
Completed N=35
Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT00225212 ↗Enrolled (actual)
35
Serious AEs
94.3%
Results posted
Sep 2014
Primary outcomePrimary: Event-free Survival (EFS) — 83 percentage of not experiencing EFS event
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival (EFS) |
83 | — |
| SECONDARY Overall Survival (OS) |
88 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00225212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.