Phase 2
N=63
Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma
B-cell Adult Acute Lymphoblastic Leukemia · B-cell Childhood Acute Lymphoblastic Leukemia · B-cell Chronic Lymphocytic Leukemia · Childhood Burkitt Lymphoma · Childhood Diffuse Large Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00867529 ↗Enrolled (actual)
63
Serious AEs
7.9%
Results posted
May 2017
Primary outcome: Primary: Disease Relapse Rate — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rituximab (Biological); peripheral blood stem cell transplantation (Procedure); nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure); pharmacological study (Other); laboratory biomarker analysis (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Mar 2015
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 | — |
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.
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.