Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This clinical trial studies donor lymphocyte infusion in treating patients with persistent, relapsed, 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 after a donor hematopoietic cell transplant

Further Study Information

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 receive unirradiated DLI over 15-30 minutes on day 0. Patients undergo restaging on day 28 and may receive 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.

Eligibility 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], Hodgkin's lymphoma 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 interferon (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 cluster of differentiation (CD)3 cells (> 5% donor CD3 cells by a deoxyribonucleic acid [DNA]-based assay that compares the profile of amplified 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 collected cryopreserved peripheral blood stem cells (PBSC) after mobilization with granulocyte colony-stimulating factor (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)

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Fred Hutchinson Cancer Research Center

Brenda Sandmaier

Principal Investigator

U.S.A.
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		Seattle Cancer Care Alliance	Ph: 800-804-8824
		Brenda Sandmaier	Principal Investigator
	Veterans Administration Center-Seattle
		Thomas R. Chauncey	Ph: 206-764-2709
		Thomas R. Chauncey	Principal Investigator
Germany
	Leipzig
	Universitaet Leipzig
		Dietger Niederwieser	Ph: 0341-97-13050
		Dietger Niederwieser	Principal Investigator
Italy
	Torino
	Universita di Torino
		Benedetto Bruno	Ph: 29-011-6334419
		Benedetto Bruno	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00068718
Information obtained from ClinicalTrials.gov on January 30, 2012

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