Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant

Last updated: January 15, 2020
Sponsor: Fred Hutchinson Cancer Research Center
Overall Status: Completed

Phase

1/2

Condition

Lymphoma

Leukemia

Multiple Myeloma

Treatment

N/A

Clinical Study ID

NCT00068718
1803.00
1803.00
P01CA078902
P30CA015704
NCI-2010-00163
  • All Genders

Study Summary

This phase I/II trial studies the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent, relapsed (disease that has returned), or progressing cancer after donor hematopoietic cell transplantation. White blood cells from donors may be able to kill cancer cells in patients with cancer that has come back (recurrent) after a donor hematopoietic cell transplant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Only patients having received a preceding nonmyeloablative allogeneic transplantationwith fludarabine/2 Gy total-body irradiation (TBI) - 4 Gy TBI or 2 Gy TBI - 4 Gy TBIconditioning from either a related or unrelated donor are eligible for this protocol

  • Patients with persistent, relapsed or progressing malignancy after nonmyeloablativeallogeneic transplantation; persistent disease will be defined as a failure to achievea response as compared to baseline

  • Patients with rapidly progressing malignancies (acute myeloid leukemia [AML], acutelymphocytic leukemia [ALL], blastic phase chronic myelogenous leukemia [CML-BC]intermediate-high-grade non-Hodgkin lymphoma [NHL], Hodgkin's lymphoma or aggressivemultiple myeloma [MM]) should receive salvage chemotherapy or radiation before DLIaccording to the recommendation made in this protocol; any form of salvagechemotherapy should be discontinued no less than 3 weeks before DLI; therapy withGleevec or interferon (IFN)-alpha should be discontinued prior to DLI; after salvagechemotherapy restaging is performed, patients with progressive disease and patientsnot meeting the inclusion criteria of the study after chemotherapy will be excludedfrom the study; patients are allowed to receive further doses of chemotherapy afterDLI administration if they are scheduled for further DLI; after additional therapy thepatients must be restaged and must again meet inclusion criteria to receive furtherDLI

  • Patients must be able to tolerate a taper of systemic steroids to a dosage of lessthan or equal to 0.25 mg/kg/day; all other immunosuppressive therapy must have beendiscontinued for at least two weeks without significant flares in GVHD (i.e., increaseof acute GVHD by one or more grades)

  • Patients must have persistent donor cluster of differentiation (CD)3 cells (> 5% donorCD3 cells by a deoxyribonucleic acid [DNA]-based assay that compares the profile ofamplified fragment length polymorphisms [ampFLP] [or fluorescent in situ hybridization (FISH) studies or variable number tandem repeat (VNTR)])

  • DONOR: Alternatively to a fresh unmodified leukapheresis product, previously collectedcryopreserved peripheral blood stem cells (PBSC) after mobilization with granulocytecolony-stimulating factor (G-CSF) or cryopreserved unmodified leukapheresis productfrom the original donor can be used; if cryopreserved product is not available, theDLI 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 ofcentral venous catheter (femoral or subclavian)

  • DONOR: Donor must be medically fit to undergo the apheresis procedure (institutionalguidelines for apheresis)

Exclusion

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 bloodmononuclear cells (PBMC) by continuous centrifugation according to the criteria of theAmerican 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

Study Design

Total Participants: 35
Study Start date:
May 01, 2003
Estimated Completion Date:
April 30, 2013

Study Description

PRIMARY OBJECTIVES:

I. To assess the safety of donor lymphocyte infusion (DLI) as adoptive immunotherapy for persistent or relapsed malignant diseases in patients after related or unrelated nonmyeloablative transplantation.

SECONDARY OBJECTIVES:

I. To determine disease response, progression free and overall survival, chimerism, grade of graft-versus-host disease (GVHD), and infections.

OUTLINE:

Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.

After completion of study treatment, patients are followed up periodically.

Connect with a study center

  • Universitaet Leipzig

    Leipzig, D-04103
    Germany

    Site Not Available

  • University of Torino

    Torino, 10126
    Italy

    Site Not Available

  • OHSU Knight Cancer Institute

    Portland, Oregon 97239
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington 98109
    United States

    Site Not Available

  • VA Puget Sound Health Care System

    Seattle, Washington 98101
    United States

    Site Not Available

  • Froedtert Memorial Lutheran Hospital, Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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