Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants

Completed · Phase 2

Conditions studied: Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome

In brief

Bone marrow stem cell transplants (otherwise called bone marrow transplants) from healthy donors are sometimes the only means of curing hematological malignant diseases such as acute and chronic leukemias, myelodysplastic syndrome, myeloproliferative diseases and lymphomas. Before transplant the patient receives chemotherapy and radiation treatment to reduce the malignancy to low levels and to prevent rejection of the transplant. The transplant restores the blood counts to normal and replaces the patients immunity with that of the donor. The donors immune cells increase the effect of the transplant by attacking remaining malignant cells. Donor immune cells (especially those called T lymphocytes) also attack healthy non-cancerous cells and tissues of the recipient causing "graft-versus-host-disease" (GVHD). Strong GVHD reactions occurring within weeks after the transplant can be life-threatening . In this study we remove most of the T lymphocytes from the transplant to minimize the risk of GVHD. However to improve immunity against residual malignant cells and boost immunity to infections, donor T cells (stored frozen at time of transplant) are given back around 90 days after the transplant when they have a reduced risk of causing serious GVHD. Any patient between 10 and 75 years of age with acute or chronic leukemia, myelodysplastic syndrome, myeloproliferative syndromes or lymphoma, who have a family member who is a suitable stem cell donor may be eligible for this study. Candidates are screened with a medical history and various tests and examinations.

Key facts

Study ID
NCT00378534
Run by
National Heart, Lung, and Blood Institute (NHLBI)
People needed
116
Starts
2006-09-01
Expected to finish
2014-04-01
Last updated by the study team
2021-06-16

Who can join

Age: 10 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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