Protocol Number: 99-H-0046

Title:

Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed by T-Cell Add-Back for Hematological Malignancies - Role of Cyclosporine

Number:

99-H-0046

Summary:

Cancers of the blood, sometimes referred to as hematologic malignancies, are disorders of bone marrow cells that lead to the failure of the normal function of bone marrow and the uncontrolled growth of cancerous cells in the bone marrow. These cancerous cells can spill over into the bloodstream and affect other organs causing widespread symptoms. The disease is life threatening because it blocks the normal function of the marrow, which is to produce red cells (preventing anemia), white cells (preventing infection), and platelets (preventing progression).

Bone marrow transplants are a potential form of therapy for patients with hematologic malignancies. However, BMT is a complicated procedure and can be associated with dangerous side effects.

In this study researchers are attempting to find ways to reduce the complications of BMT, so that it would be possible to use it more safely and can be offered more patients. In order to do this, researchers are developing new techniques to make BMT safer. It requires making small changes to the standard procedure, which may improve the outcome.

The experimental procedures researchers are evaluating are:

1. T-cell depleted peripheral blood progenitor cell (PBPC) transplantation

2. Cyclosporine given immediately after the transplant

3. Add-back of donor lymphocytes

Patients undergoing these experimental techniques must be monitored closely to see if any benefit or harmful effects will occur. Information gathered from this study can be used to develop further research studies and potential new therapies for hematologic malignancies.

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:

Peripheral Blood Stem Cells

Cyclosporine

Cyclosphosphamide

Whole Body Irradiation

Donor Apheresis

Leukemic Relapse

Graft vs. Host Disease

Graft-Versus-Leukemia

Graft-Versus-Myeloma

Recruitment Keywords:

Chronic Myelogenous Leukemia

Acute Lymphoblastic Leukemia

Acute Myelogenous Leukemia

Myelodysplastic Syndromes

Multiple Myeloma

Chronic Lymphocytic Leukemia

Non-Hodgkin's Lymphoma

Conditions:

Chronic Lymphocytic Leukemia

Graft vs Host Disease

Hematologic Neoplasm

Multiple Myeloma

Myelodysplastic Syndrome

Investigational Drug(s):

None

Investigational Device(s):

Isolex 300i plus MoAbs

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:

Primary transpantation of allogeneic peripheral blood progenitor cells mobilized by Filgastrim (G-CSF)

Transplantation of allogeneic perpheral blood stem cells mobilized by recombinant human granulocyte-stimulating factor

Peripheral blood progenitor cell transplantion: A replacement for marrow auto- or allografting

• 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.

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Bethesda, Maryland 20892. Last update: 10/15/2004