Rituximab in Preventing Acute Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

This study is currently recruiting participants.
Verified March 2011 by University of Nebraska

First Received on January 7, 2010.  
Last Updated on March 23, 2011  
History of Changes
This Clinical Trial Sponsored By: University of Nebraska
Collaborator: National Cancer Institute (NCI)
Information provided by: University of Nebraska
ClinicalTrials.gov Identifier: NCT01044745
 

Purpose for Clinical Trial

RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient’s immune system from rejecting the donor’s stem cells. The donated stem cells may replace the patient’s immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body’s normal cells. Giving a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer

Condition Study Intervention Clinical Trial Phase
Leukemia, Myeloid, Accelerated Phase
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Blast Phase
Contiguous Stage II Adult Burkitt’s Lymphoma
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Contiguous Stage II Adult Lymphoblastic Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Contiguous Stage II Marginal Zone Lymphoma
Contiguous Stage II Small Lymphocytic Lymphoma
De Novo Myelodysplastic Syndromes
Mucosa-Associated Lymphoid Tissue Lymphoma
Graft Versus Host Disease
Monocytoid B-cell Lymphoma
Noncontiguous Stage II Adult Burkitt’s Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt’s 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 Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Adult T-cell Lymphoma/Leukaemia Recurrent
Cutaneous T-cell Lymphoma Recurrent
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Mantle Cell Lymphoma Recurrent
Recurrent Marginal Zone Lymphoma
Mycosis Fungoides/Sezary Syndrome Recurrent
B-cell Small Lymphocytic Lymphoma Recurrent
Chronic Lymphocytic Leukaemia Refractory
Chronic Myelogenous Leukemia in Relapse
Secondary Myelodysplastic Syndromes
Splenic Marginal Zone B-Cell Lymphoma
Stage I Adult Burkitt’s Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Stage I Adult Diffuse Mixed Cell Lymphoma
Stage I Adult Diffuse Small Cleaved Cell Lymphoma
Stage I Adult Immunoblastic Large Cell Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Adult T-cell Lymphoma/Leukaemia Stage I
Chronic Lymphocytic Leukaemia Stage 1
Cutaneous T-cell Lymphoma Stage I
Stage I Grade 1 Follicular Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage I Grade 3 Follicular Lymphoma
Mantle Cell Lymphoma Stage I
Stage I Marginal Zone Lymphoma
Mycosis Fungoides/Sezary Syndrome Stage I
B-cell Small Lymphocytic Lymphoma Stage I
Adult T-cell Lymphoma/Leukaemia Stage II
Chronic Lymphocytic Leukaemia Stage 2
Cutaneous T-cell Lymphoma Stage II
Mycosis Fungoides/Sezary Syndrome Stage II
Stage III Adult Burkitt’s Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Adult T-cell Lymphoma/Leukaemia Stage III
Chronic Lymphocytic Leukaemia Stage 3
Cutaneous T-cell Lymphoma Stage III
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Mantle Cell Lymphoma Stage III
Stage III Marginal Zone Lymphoma
Mycosis Fungoides/Sezary Syndrome Stage III
B-cell Small Lymphocytic Lymphoma Stage III
Stage IV Adult Burkitt’s Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Adult T-cell Lymphoma/Leukaemia Stage IV
Chronic Lymphocytic Leukaemia Stage 4
Cutaneous T-cell Lymphoma Stage IV
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Mantle Cell Lymphoma Stage IV
Stage IV Marginal Zone Lymphoma
Mycosis Fungoides/Sezary Syndrome Stage IV
B-cell Small Lymphocytic Lymphoma Stage IV
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Myeloid Leukemia
Waldenstrom Macroglobulinemia
Drug: rituximab
Drug: mycophenolate mofetil
Drug: tacrolimus
Drug: anti-thymocyte globulin
Procedure: allogeneic hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Biological: graft versus host disease prophylaxis/therapy
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: busulfan
Radiation: total-body irradiation
Biological: graft-versus-tumor induction therapy
Biological: immunosuppressive therapy
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: RITUXIMAB FOR PREVENTION OF ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) AFTER UNRELATED DONOR ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT)

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
familial acute myeloid leukemia with mutated CEBPA
hemophilia
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fungal Infections
Leukemia

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