Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-Cell Lymphoma

This study is currently recruiting participants.
Verified March 2012 by Fred Hutchinson Cancer Research Center

First Received on March 20, 2009.  
Last Updated on March 14, 2012  
History of Changes
This Clinical Trial Sponsored By: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborator: National Cancer Institute (NCI)
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00867529
 

Purpose for Clinical Trial

This clinical trial studies rituximab in treating patients undergoing donor peripheral blood stem cell transplant for relapsed or refractory B-cell lymphoma. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Giving rituximab before and after donor peripheral blood stem cell transplant may kill more cancer cells and may help the patient’s immune system from rejecting the donor’s stem cells

Condition Study Intervention Clinical Trial Phase
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 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 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
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Biological: rituximab
Genetic: polymorphism analysis
Other: pharmacological study
Other: laboratory biomarker analysis
Procedure: peripheral blood stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Hodgkin Disease
Lymphoma
Drug Information available for:
Rituximab

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures For Clinical Trial:

  • Effectiveness of pre- and post-transplant rituximab in decreasing the disease relapse rate [ Time Frame: At 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Incidence and severity of acute and chronic GVHD evaluated per an adapted version of Common Terminology Criteria for Adverse Events (CTCAE) v2.0 [ Time Frame: Through day +100 after transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2009
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Treatment (monoclonal antibody therapy and transplant)

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.
Biological: rituximab

Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan

Genetic: polymorphism analysis

Correlative studies

Other: pharmacological study

Correlative studies
Other Name: pharmacological studies

Other: laboratory biomarker analysis

Correlative studies

Procedure: peripheral blood stem cell transplantation

Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation
Other Names:
  • PBPC transplantation
  • PBSC transplantation
  • peripheral blood progenitor cell transplantation
  • transplantation, peripheral blood stem cell

Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation

Detailed 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 FCgammaRIIIa receptor 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 at 1 year and then annually thereafter.

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