Phase
Condition
Lymphoma
Leukemia
Multiple Myeloma
Treatment
N/AClinical Study ID
All Genders
Study Summary
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
Study Description
Connect with a study center
Universitaet Leipzig
Leipzig, D-04103
GermanySite Not Available
University of Torino
Torino, 10126
ItalySite Not Available
OHSU Knight Cancer Institute
Portland, Oregon 97239
United StatesSite Not Available
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington 98109
United StatesSite Not Available
VA Puget Sound Health Care System
Seattle, Washington 98101
United StatesSite Not Available
Froedtert Memorial Lutheran Hospital, Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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