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A Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Stem Cell Transplantation

Phase 1/Phase 2
18 Years
Not Enrolling
Hematological Malignancies

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Trial Information

A Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Stem Cell Transplantation

Study Design: The study is designed as a Phase II, open label trial of Rituximab as chronic
GVHD prophylaxis after HLA-matched, related or unrelated peripheral blood stem cell
transplantation after ablative or non-ablative conditioning.

Primary Objective: To determine the incidence of clinically extensive chronic GVHD at one
and two years after allogeneic stem cell transplantation after a single dose of Rituximab
administered at 100 days, 6 months, 9 months and 1 year from transplantation as chronic GVHD

Secondary Objectives: To determine the incidence of adverse hematological events, the
incidence of infectious complications, the rate of malignant relapse, and the effects on
donor hematopoietic chimerism after Rituximab administration.

Eligibility Criteria: Eligible patients will be 18 years of age or greater and will have
undergone a non-myeloablative or fully ablative transplantation from an HLA-matched (6/6
loci) or single antigen/allele mismatched (5/6) donor approximately 100 days ago. Adequate
performance status and organ function will be confirmed prior to enrollment. No ongoing
infection or acute GVHD will be present at the time of enrollment. Evidence of sustained
donor chimerism will be confirmed prior to study entry.

Treatment Description: Chronic GVHD prophylaxis will consist of Rituximab 375 mg/m2
administered 100 days, 6, 9 and 12 months after transplantation.

Accrual Objective: 68 patients will be accrued over 12 months.

Study Duration: Patients will be evaluated for two years after the time of transplantation
for evaluation of the primary and secondary endpoints. Subjects will be followed
longitudinally after completion of the study period for determination of clinical status.

Inclusion Criteria:

- Patients who have undergone either ablative or non-myeloablative allogeneic stem cell

- Peripheral blood stem cells must have been used as the stem cell source

- Patients must have received transplantation from donors who are identical at 6 HLA
loci, or mismatched at no more than 1 locus.

- Patients who have undergone a non-myeloablative stem cell transplant must have > 80%
donor hematopoiesis within 30 days of study enrollment

- 18 years of age or older

- Performance Status 0-2

- Life expectancy of > 100 days

- Subjects with CLL are eligible, if there is no more than 20% residual leukemia in the
bone marrow at the time of study entry

Exclusion Criteria:

- Evidence of relapsed or residual malignancy within 30 days of trial entry

- Highly aggressive B cell malignancy, such as Burkitt's lymphoma or Burkitt's-like

- Allogeneic stem cell transplantation using a single or multiple umbilical cord blood
units or using bone marrow

- Evidence of any active uncontrolled infection, or evidence of natural exposure to
Hepatitis B, Hepatitis C or HIV

- Evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater
than ongoing Stage I cutaneous acute GVHD

- GVHD with chronic features diagnosed prior to day +100 or prior to enrollment

- Participation in a clinical trial evaluating another preventative strategy for
chronic GVHD, or ongoing participation in a clinical trial for therapy of acute GVHD

- No Donor Lymphocyte Infusion (DLI) prior to day 100 and not plans for a DLI in the
upcoming 30 days

- Heart failure uncontrolled by medications

- Pregnancy or lactation

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

The incidence of clinically extensive chronic GVHD at one and two years

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Corey Cutler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

August 2012

Related Keywords:

  • Hematological Malignancies
  • Rituximab
  • Chronic GVHD
  • Neoplasms
  • Hematologic Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115