Protocol Number: 03-H-0192

Title:

Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed by T Cell Add-back for Hematological Malignancies - Effect of Irradiated Donor Lymphocytes on Chimerism

Number:

03-H-0192

Summary:

Bone marrow transplantation (BMT) is a risky procedure. If doctors could reduce the complications, BMT would be safer to use for a wider range of conditions. The purposes of this study are

- to prevent graft rejection by increasing the amount of immunosuppression and by giving some lymphocytes from the donor before transplant;

- to prevent graft-versus-host disease (GVHD) by transplanting T-cell depleted stem cells;

- to improve the immune effect against residual leukemia by the add-back of donor lymphocytes before transplant and six or more weeks after transplant.

Beyond the standard BMT protocol, study participants will undergo additional procedures. First, along with total body irradiation, patients will receive two drugs (a high dose of cyclophosphamide and fludarabine) to suppress immunity and prevent rejection of the transplant. Second, four days before the transplant, patients will be given donor lymphocytes that have been irradiated to make them incapable of causing GVHD. On the day of the transplant, patients will receive an infusion of T-cell depleted bone marrow stem cells. Finally, patients will receive two doses of add-back donor T-cells (45 and 100 days post transplant) and the immunosuppressive drug cyclosporine starting on day 44 until about six months after transplant.

Study participants must be between the ages of 10 and 56 and have a family member who is a suitable stem cell donor match.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Chronic Myelogenous Leukemia

Acute Lymphoblastic Leukemia

Acute Myelogenous Leukemia (AML)

Chronic Lymphocytic Leukemia

Myelodysplastic Syndrome

Non-Hodgkin's Lymphoma

Graft-versus Leukemia/Myeloma

Graft-versus-host Disease

Cyclosporine

Fludarabine

Recruitment Keywords:

Chronic Myelogenous Leukemia

Acute Lymphoblastic Leukemia

Acute Myelogenous Leukemia (AML)

Chronic Lymphocytic Leukemia

Myelodysplasia Syndrome

Non-Hodgkin's Lymphoma

Conditions:

Acute Lymphocytic Leukemia

Chronic Myeloid Leukemia

Acute Myelocytic Leukemia

Myelodysplastic Syndromes

Myeloproliferative Disorders

Investigational Drug(s):

None

Investigational Device(s):

Isolex 300i Stem Cell Selection

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Couriel D, Canosa J, Engler H, Collins A, Dunbar C, Barrett AJ. Early reactivation of cytomegalovirus and high risk of interstitial pneumonitis following T-depleted BMT for adults with hematological malignancies. Bone Marrow Transplant. 1996 Aug;18(2):347-53. PMID: 8864445

Mavroudis D, Read E, Cottler-Fox M, Couriel D, Molldrem J, Carter C, Yu M, Dunbar C, Barrett J. CD34+ cell dose predicts survival, posttransplant morbidity, and rate of hematologic recovery after allogeneic marrow transplants for hematologic malignancies. Blood. 1996 Oct 15;88(8):3223-9. PMID: 8874224

Mavroudis DA, Read EJ, Molldrem J, Raptis A, Plante M, Carter CS, Phang S, Dunbar CE, Barrett AJ. T cell-depleted granulocyte colony-stimulating factor (G-CSF) modified allogenic bone marrow transplantation for hematological malignancy improves graft CD34+ cell content but is associated with delayed pancytopenia. Bone Marrow Transplant. 1998 Mar;21(5):431-40. PMID: 9535034

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004