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Graft-Versus-Host Disease

Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant (FHCRC-1825)
Pentostatin and Donor Lymphocyte Infusion for Low Donor T-Cell Chimerism After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multicenter Trial
Status Conditions Phase Study ID
Recruiting 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 Syndromes (MDS and MPD)
Non-Hodgkin's Lymphoma (NHL)
Phase I/II FHCRC-1825
NCT00096161
Summary

RATIONALE: 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. PURPOSE: This clinical trial studies pentostatin and donor lymphocyte infusion in preventing graft rejection in patients who have undergone donor stem cell transplant


Investigator
Brenda Sandmaier, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 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 DNA-based assay that compares the profile of amplified fragment length polymorphisms [ampFLP] [or FISH studies or VNTR])
  • DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collected cryopreserved peripheral blood stem cells (PBSC) after mobilization with G-CSF or crypreserved unmodified leukapheresis product from the original donor can be used; if cryopreserved product is not available, the DLI product must be from the original donor of hematopoietic cell transplantation.
  • 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)
Exclusions (conditions that would prevent participation in this study)

Exclusion Criteria:

  • Current grade II to IV acute GVHD or extensive chronic GVHD
  • 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
Last Updated
October 25, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.