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Complete title: Pentostatin and Donor Lymphocyte Infusion for Low Donor T-Cell Chimerism After Hematopoietic Cell Transplantation - A Multicenter Trial
|Research Study Number||1825.00|
|Principal Investigator||Brenda Sandmaier, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
- Only patients having received a preceding nonmyeloablative allogeneic transplantation with fludarabine/2-3 Gy total-body irradiation (TBI) or 2 Gy TBI conditioning from either a related or unrelated donor are eligible for this protocol
- Patients with less than 50% donor CD3 peripheral blood chimerism on two separate, consecutive evaluations (the two evaluations must be at least 14 days apart) OR patients with absolute decreases of donor CD3 peripheral blood chimerism of >= 20% if the second test shows < 50% donor CD3 cells (the two evaluations must be at least 14 days apart)
- Patients with evidence of disease are only eligible if the disease is stable (or persistent) in comparison to the status prior to transplantation
- Patients must be tapered off systemic steroids to a dosage of less than or equal to 0.25 mg/kg/day; additionally, all other immunosuppressive therapy will be discontinued before administration of pentostatin
- Patients must have persistent donor CD3 cells (>= 5% donor CD3 cells by a deoxyribonucleic acid (DNA)-based assay that compares the profile of amplified fragment length polymorphisms [ampFLP] [or fluorescent in situ hybridization (FISH) studies or variable number of tandem repeats (VNTR)])
- DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collected cryopreserved peripheral blood stem cells (PBSC) after mobilization with G-CSF or cryopreserved unmodified leukapheresis product from the original donor can be used; if cryopreserved product is not available, the following criteria apply for the DLI product:
- DONOR: Original donor of hematopoietic cell transplantation
- DONOR: Donor must give consent to leukapheresis
- DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral or subclavian)
- DONOR: Donor must be medically fit to undergo the apheresis procedure (institutional guidelines for apheresis)
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Karnofsky score < 50%
- Lansky Play-Performance Score < 40
- Evidence of relapse or progression of disease after transplantation
- DONOR: Donor who are not suitable for medical reasons to donate peripheral blood mononuclear cells (PBMC) by continuous centrifugation according to the criteria of the American Association of Blood Banks (AABB)
- DONOR: Pregnancy
- DONOR: Human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection
- DONOR: Recent immunization may require a delay
Other exclusion criteria may apply.
Acute Lymphoid Leukemia (ALL); Acute Myeloid Leukemia (AML); Chronic Lymphoid Leukemia (CLL); Chronic Myeloid Leukemia (CML); Hematologic Malignancies; Hodgkin's Lymphoma; Leukemia; Lymphoma; Multiple Myeloma (MM); Myelodysplastic and Myeloproliferative S
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