Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant
NCT00096161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2020-01-31
Summary
This phase II trial studies pentostatin and donor lymphocyte infusion in preventing graft rejection in patients who have undergone donor stem cell transplant. Giving pentostatin and an infusion of the donor's T cells (donor lymphocyte infusion) after a donor stem cell transplant may stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before donor lymphocyte infusion may stop this from happening.
Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Chronic Lymphocytic Leukemia
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Graft Versus Host Disease
- Hodgkin Lymphoma
- Myelodysplastic/Myeloproliferative Neoplasm
- Non-Hodgkin Lymphoma
- Plasma Cell Myeloma
- Waldenstrom Macroglobulinemia
Interventions
- DRUG
-
Cyclosporine
Given PO
- DRUG
-
Mycophenolate Mofetil
Given PO
- DRUG
-
Pentostatin
Given IV
- BIOLOGICAL
-
Therapeutic Allogeneic Lymphocytes
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Brenda Sandmaier · Fred Hutch/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-05-31
- Primary Completion
- 2015-02-28
- Completion
- 2015-08-31
Countries
- United States
- Italy
Study Locations
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