Phase 2
Completed N=63
Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma
Source: ClinicalTrials.gov NCT00867529 ↗Enrolled (actual)
63
Serious AEs
7.9%
Results posted
May 2017
Primary outcomePrimary: Disease Relapse Rate — 18 Participants
Summary
This phase II trial studies giving rituximab before and after a donor peripheral blood stem cell transplant in patients with B-cell lymphoma that does not respond to treatment (refractory) or has come back after a period of improvement (relapsed). Monoclonal antibodies, such as rituximab, can interfere with the ability of cancer cells to grow and spread. Giving rituximab before and after a donor peripheral blood stem cell transplant may help stop cancer from coming back and may help keep the patient's immune system from rejecting the donor's stem cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Relapse Rate |
18 | — |
| SECONDARY Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 |
17 | — |
| SECONDARY Overall Survival and Progression-free Survival |
48; 39; 34; 52; 44; 36 | — |
| SECONDARY Rate of Graft Rejection and Graft Failure |
1; 0 | — |
| SECONDARY Time to Engraftment |
10 | — |
Eligibility Criteria
Inclusion Criteria
- With a diagnosis of CD20-expressing B-cell malignancy of any histologic type or grade for whom non-myeloablative allogeneic transplant is considered an appropriate treatment option
- Who are enrolled on a non-myeloablative allogeneic HCT protocol employing total-body irradiation (TBI)-based conditioning of = = 18 years of age), or with a legal guardian capable of giving consent (if < 18 years of age)
Exclusion Criteria
- Ineligible for non-myeloablative allogeneic HCT
- Receiving an HLA-haploidentical allograft
- Who are fertile but unwilling to use contraception during and for at least 12 months after HCT
- Females who are pregnant or breast-feeding
Data sourced from ClinicalTrials.gov (NCT00867529). 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.