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Bone Marrow Transplant

Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant (FHCRC-1803)
Donor Lymphocyte Infusion for the Treatment Of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial
Status Conditions Phase Study ID
Closed Acute Lymphoid Leukemia (ALL)
Acute Myeloid Leukemia (AML)
Chronic Myeloid Leukemia (CML)Hodgkin's Lymphoma
Juvenile Myeloid Leukemia (JML)
Multiple Myeloma (MM)
Non-Hodgkin's Lymphoma (NHL)
Phase I/II FHCRC-1803

RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with cancer that has come back after a donor hematopoietic cell transplant. PURPOSE: This clinical trial studies donor lymphocyte infusion in treating patients with persistent, relapsed, or progressing cancer after donor hematopoietic cell transplantation

Brenda Sandmaier, MD
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

Inclusion Criteria:

  • Only patients having received a preceding nonmyeloablative allogeneic transplantation with fludarabine/2 Gy total-body irradiation (TBI) - 4 Gy TBI or 2 Gy TBI - 4 Gy TBI conditioning from either a related or unrelated donor are eligible for this protocol
  • Patients with persistent, relapsed or progressing malignancy after nonmyeloablative allogeneic transplantation (persistent disease will be defined as a failure to achieve a response as compared to baseline)
  • Patients with rapidly progressing malignancies (acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), blastic phase chronic myelogenous leukemia (CML-BC), intermediate-high-grade non-Hodgkin lymphoma (NHL), Hodgkins disease or aggressive multiple myeloma (MM)) should receive salvage chemotherapy or radiation before DLI according to the recommendation made in this protocol; any form of salvage chemotherapy should be discontinued no less than 3 weeks before DLI; therapy with Gleevec or IFN-alpha should be discontinued prior to DLI; after salvage chemotherapy restaging is performed, patients with progressive disease and patients not meeting the inclusion criteria of the study after chemotherapy will be excluded from the study; patients are allowed to receive further doses of chemotherapy after DLI administration if they are scheduled for further DLI; after additional therapy the patients must be restaged and must again meet inclusion criteria to receive further DLI
  • Patients must be able to tolerate a taper of systemic steroids to a dosage of less than or equal to 0.25 mg/kg/day; all other immunosuppressive therapy must have been discontinued for at least two weeks without significant flares in GVHD (i.e., increase of acute GVHD by one or more grades)
  • 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 cryopreserved 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 for pediatric patients
  • DONOR: Donors 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
July 25, 2012
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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