Protocol Number: 97-H-0099

Title:

HLA-Matched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed by T Cell Add-Back for Hematological Malignancies

Number:

97-H-0099

Summary:

Bone marrow transplants (BMT) are one of the accepted therapies used to treat leukemia. However, BMT have risks of complications. One potentially life-threatening complication is known as graft-versus-host disease (GVHD).

The GVHD is a reaction caused by an incompatibility between donor cells and recipient cells. Antigens found on the recipient's cells are recognized by the donor's transplanted white blood cell lymphocytes. These lymphocytes begin attacking the recipient's cells and tissues and may lead to death.

One of the most effective ways to prevent this reaction is to remove the lymphocytes from the transplanted marrow. Unfortunately, without lymphocytes the recipient's immune system will be lowered and may result in a relapse of leukemia or an infection.

Researchers have shown they can perform effective BMT by removing the lymphocytes prior to the transplant and then later adding the lymphocytes back. This technique can reduce the potential for GVHD and preserve the graft-versus-leukemia (GVL) effect of the transplant.

In this study researchers plan to use peripheral blood with lymphocytes removed rather than bone marrow. In order to increase the number of progenitor cells, the cells responsible for correcting the leukemia, donors will receive doses of G-CSF prior to the transplant. G-CSF (granulocyte colony stimulating factor) is a growth factor that increases the production of progenitor cells in the donor's blood stream.

The study will be broken into two parts. The first part of the study will attempt to determine if peripheral blood with lymphocytes removed can prevent GVHD while preserving the GVL effect of the transplant.

In the second part of the study, patients that received the transplant will have the lymphocytes added-back on two separate occasions in order reduce the chances of relapse and infection.

The study is designed to treat up to 55 patients ages 10 to 60 years and follow their progress for 5 years.

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: Yes

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

Graft-Versus-Leukemia

Graft vs. Host Disease

Whole Body Irradiation

Donor Apheresis

Cyclophosphamide

Graft-Versus-Myeloma

Leukemic Relapse

Recruitment Keywords:

Multiple Myeloma

Acute Myelogenous Leukemia (AML)

Chronic Myelogenous Leukemia (CML)

Acute Lymphoblastic Leukemia (ALL)

Myelodysplastic Syndromes

Chronic Lymphocytic Leukemia (CLL)

Conditions:

Graft vs Host Disease

Hematologic Neoplasm

Leukemia

Multiple Myeloma

Myelodysplastic Syndrome

Investigational Drug(s):

None

Investigational Device(s):

None

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:

CD34+ cell dose predicts survival, post transplant morbidity and rate of hematologic recovery following allogeneic marrow transplants for hematologic malignancies

T cell depleted bone marrow transplantation and delayed T cell add-back to control acute GVHD and conserve a graft versus leukemia effect

Graft-versus-leukemia: Understanding and using the alloimmune response to treat hematological malignancies

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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