Laboratory-Treated Donor Bone Marrow in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer

Johns Hopkins Medicine

Status and phase

Completed

Phase 3

Conditions

Graft Versus Host Disease

Multiple Myeloma and Plasma Cell Neoplasm

Lymphoma

Leukemia

Myelodysplastic/Myeloproliferative Diseases

Myelodysplastic Syndromes

Treatments

Procedure: allogeneic bone marrow transplantation

Biological: graft versus host disease prophylaxis/therapy

Procedure: in vitro-treated bone marrow transplantation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00265837

J0165 CDR0000454926

JHOC-J0165

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-WIRB-20020342

JHOC-WIRB-1908

P01CA015396 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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