Phase 2 N=35 Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT00225212 ↗

Enrolled (actual)

Serious AEs

94.3%

Results posted

Sep 2014

Primary outcome: Primary: Event-free Survival (EFS) — 83 percentage of not experiencing EFS event

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rituximab 375 mg/m2 (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Mar 2003

Outcome Measures

Outcome	Result	p-value
PRIMARY Event-free Survival (EFS)	83	—
SECONDARY Overall Survival (OS)	88	—

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.

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

View full record on ClinicalTrials.gov →

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.