Overview

This trial is active, not recruiting.

Conditions 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, childhood immunoblastic large cell lymphoma, cutaneous b-cell non-hodgkin lymphoma, extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue, intraocular lymphoma, nodal marginal zone b-cell lymphoma, post-transplant lymphoproliferative disorder, recurrent adult acute lymphoblastic leukemia, recurrent adult burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade iii lymphomatoid granulomatosis, recurrent adult hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent childhood acute lymphoblastic leukemia, recurrent childhood grade iii lymphomatoid granulomatosis, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, recurrent/refractory childhood hodgkin lymphoma, refractory chronic lymphocytic leukemia, refractory hairy cell leukemia, small intestine lymphoma, splenic marginal zone lymphoma, testicular lymphoma, waldenström macroglobulinemia
Treatments rituximab, peripheral blood stem cell transplantation, nonmyeloablative allogeneic hematopoietic stem cell transplantation, pharmacological study, laboratory biomarker analysis
Phase phase 2
Target CD20
Sponsor Fred Hutchinson Cancer Research Center
Collaborator American Cancer Society, Inc.
Start date February 2009
End date March 2015
Trial size 100 participants
Trial identifier NCT00867529, 2226, 2226.00, NCI-2010-00107, P01CA078902, P30CA015704

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
rituximab IDEC-C2B8
Given IV
peripheral blood stem cell transplantation PBPC transplantation
Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
pharmacological study pharmacological studies
Correlative studies
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Disease relapse rate
time frame: At 18 months

Secondary Outcomes

Measure
Incidence and severity of acute and chronic GVHD evaluated per an adapted version of Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
time frame: Through day +100 after transplant

Eligibility Criteria

Male or female participants of any age.

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 =< 4.5 Gy, with or without fludarabine; this protocol may be used as an adjunct to the allogeneic arm of a tandem autologous/allogeneic transplant protocol, provided the allogeneic conditioning meets the above criteria - Receiving unmodified peripheral blood mononuclear cell graft products - With an appropriate related or unrelated donor; human leukocyte antigen (HLA)-haploidentical donors are excluded - Able to give informed consent (if >= 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

Additional Information

Official title Addition of Pre- and Post-Transplant Rituximab for Patients Undergoing Non-myeloablative Allogeneic Hematopoietic Cell Transplantation With Relapsed or Refractory CD20+ B-Cell Malignancies
Principal investigator David Maloney
Description PRIMARY OBJECTIVES: I. To determine the effect of addition of peri-transplant rituximab on relapse rate at 18 months after non-myeloablative allogeneic hematopoietic cell transplant (HCT) for cluster of differentiation (CD)20+ B-cell malignancies. SECONDARY OBJECTIVES: I. To determine overall and progression-free survival and non-relapse mortality. II. To determine the incidence and severity of acute and chronic graft-versus-host disease (GVHD). III. To determine the rate of graft rejection and graft failure. IV. To determine the time to engraftment. V. To determine the incidence of serious adverse events with the addition of rituximab. VI. To evaluate the pharmacokinetics of rituximab in the setting of non-myeloablative allogeneic HCT. VII. To describe donor and host polymorphisms of the FC gamma receptor IIIa (FCg RIIIA) and CD32 and evaluate their impact on disease response and relapse. OUTLINE: Patients receive rituximab intravenously (IV), pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for 18 months and then annually for 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Fred Hutchinson Cancer Research Center.