Non Hodgkin Lymphoma Clinical Trial
Laboratory-Treated Donor Bone Marrow in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening.
PURPOSE: This randomized phase III trial is studying donor bone marrow that is treated in the laboratory using two different devices to compare how well they work in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
Full Description
OBJECTIVES:
Compare the effectiveness, in terms of incidence of graft failure and incidence of greater than grade 1 acute graft-vs-host disease, of ex vivo manipulation of bone marrow cells comprising counterflow centrifugal elutriation for T-lymphocyte depletion followed by CD34-positive stem cell selection using CliniMACS vs Isolex 300i in patients with a hematologic malignancy undergoing allogeneic bone marrow transplantation from an HLA-identical sibling donor.
OUTLINE: This is a randomized study. Patients are stratified by age (< 40 vs 40-65) and disease status (low-risk [i.e., chronic phase chronic myelogenous leukemia, acute myeloid leukemia in first complete remission (CR), acute lymphocytic leukemia in first CR, Hodgkin's or non-Hodgkin's lymphoma in sensitive relapse, or multiple myeloma in CR or partial remission) vs high-risk [i.e., all others]). Patients are randomized to 1 of 2 treatment arms.
Arm I: Allogeneic bone marrow cells are subjected to counterflow centrifugal elutriation (CCE) for T-lymphocyte depletion. The elutriation fractions are then processed over 2-2.5 hours using CliniMACS to select for CD34-positive stem cells.
Arm II: Allogeneic bone marrow cells are subjected to CCE for T-lymphocyte depletion. The elutriation fractions are then processed over 4-4.5 hours using Isolex 300i to select for CD34-positive stem cells.
Patients in both arms then undergo ex vivo manipulated, T-lymphocyte-depleted, CD34-positive stem cell-selected, allogeneic bone marrow transplantation on day 0.
After the transplantation, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 206 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies or genetic disorders:
Acute myeloid leukemia (AML), meeting 1 of the following criteria
Primary resistant disease
Disease in complete remission (CR)
Disease in first early relapse
Secondary AML arising out of myelodysplastic syndrome
Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria:
Primary resistant disease
Disease in CR
Disease in first early relapse
Chronic myelogenous leukemia
Myelodysplastic syndrome (MDS)
Chronic myelomonocytic leukemia
Philadelphia chromosome-negative myeloproliferative disorder
Multiple myeloma
Hodgkin's lymphoma
Non-Hodgkin's lymphoma
Genetic disorders or inborn errors of metabolism
Planning allogeneic bone marrow transplantation at the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins Medical Center
Must have an HLA-identical sibling donor by serologic or molecular typing of HLA class I antigens and molecular typing of HLA class II antigens
PATIENT CHARACTERISTICS:
Performance status
Not specified
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Not specified
Renal
Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior red blood cell or platelet transfusion from the same donor
Other
Concurrent participation in another clinical trial allowed
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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