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

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.

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