Bone Marrow Transplant Studies for Safe and Effective Treatment of Leukemia

Completed · Not applicable

Conditions studied: Graft vs Host Disease, Hematologic Neoplasm, Leukemia, Multiple Myeloma, Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID: NCT00001623
Run by: National Heart, Lung, and Blood Institute (NHLBI)
People needed: 41
Starts: 1997-03-27
Expected to finish: 2017-08-03
Last updated by the study team: 2019-12-12

Who can join

Age: 10 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Pregnant.
Age greater than 55 or less than 10.
ECOG performance status of 2 or more.
Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
Major anticipated illness or organ failure incompatible with survival from BMT.
DLCO less than 65% predicted.
Left ventricular ejection fraction: less than 40% predicted.
Serum creatinine greater than 3 mg/dl.
Serum bilirubin greater than 4 mg/dl.
Transaminases greater than 3 x upper limit of normal.
HIV positive.
History of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up (patient).
INCLUSION CRITERIA-DONOR:
HLA 6/6 or 5/6 matched sibling donor.
Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke).
Informed consent given.
EXCLUSION CRITERIA - DONOR:
Pregnant.
Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.
Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of stroke, thrombocytopenia).
HIV positive.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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