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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)
Leukemia
Lymphoma
Multiple Myeloma (MM)
Non-Hodgkin's Lymphoma (NHL)
Phase I/II FHCRC-1803
NCT00068718
Summary

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


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 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 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.