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

Fred Hutchinson Cancer Center (FHCC) logo

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Completed
Phase 2

Conditions

Recurrent Adult Hodgkin Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Childhood Burkitt Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Splenic Marginal Zone Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Grade 3 Follicular Lymphoma
B-cell Childhood Acute Lymphoblastic Leukemia
Recurrent Marginal Zone Lymphoma
B-cell Chronic Lymphocytic Leukemia
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Diffuse Mixed Cell Lymphoma
Post-transplant Lymphoproliferative Disorder
Small Intestine Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Testicular Lymphoma
Recurrent Mantle Cell Lymphoma
Refractory Chronic Lymphocytic Leukemia
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent/Refractory Childhood Hodgkin Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Intraocular Lymphoma
Waldenström Macroglobulinemia
Recurrent Small Lymphocytic Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
B-cell Adult Acute Lymphoblastic Leukemia
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Childhood Lymphoblastic Lymphoma
Childhood Diffuse Large Cell Lymphoma
Recurrent Childhood Large Cell Lymphoma
Refractory Hairy Cell Leukemia
Recurrent Childhood Small Noncleaved Cell Lymphoma
Recurrent Childhood Grade III Lymphomatoid Granulomatosis
Childhood Immunoblastic Large Cell Lymphoma

Treatments

Other: pharmacological study
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Procedure: peripheral blood stem cell transplantation
Biological: rituximab

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00867529
2226.00 (Other Identifier)
NCI-2010-00107 (Registry Identifier)
P01CA078902 (U.S. NIH Grant/Contract)
2226
P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

63 participants in 1 patient group

Treatment (rituximab pre- and post-transplant)
Experimental group
Description:
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.
Treatment:
Biological: rituximab
Procedure: peripheral blood stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Other: pharmacological study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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