Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	Any age	NCI	FHCRC-1803.00 5606, NCT00068718

Objectives

Primary

1. Determine the safety of donor lymphocyte infusion, in terms of the incidence of life-threatening graft-versus-host disease (GVHD), in patients with persistent, relapsed, or progressing malignancy after nonmyeloablative allogeneic transplantation.

Secondary

1. Determine disease response and progression-free and overall survival of patients treated with this regimen.
2. Determine chimerism in patients treated with this regimen.
3. Determine the grade of GVHD and infections in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Persistent, relapsed, or progressing malignancy



• Previously treated with a nonmyeloablative allogeneic transplantation from a related or unrelated donor comprising 2 Gy total body irradiation (TBI)-4 GY TBI or 2 GY TBI-4 GY TBI conditioning with or without fludarabine



• Persistent donor CD3 cells (at least 5% donor CD3 cells by fluorescent in situ hybridization or variable number of tandem repeats)



• Available leukapheresis product from the original donor of the hematopoietic cell transplantation (fresh unmodified or previously cryopreserved)



• No current grade II to IV acute graft-versus-host disease (GVHD) or extensive chronic GVHD

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• No concurrent imatinib mesylate or interferon alfa

Chemotherapy

• See Disease Characteristics
• At least 3 weeks since prior salvage chemotherapy

Endocrine therapy

• Concurrent systemic steroids allowed provided patient can tolerate a taper to a dosage of no greater than 0.25 mg/kg/day within 1 to 2 weeks prior to study therapy without experiencing an increase in GVHD of at least 1 grade

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Other

• At least 2 weeks since prior immunosuppressive therapy (e.g., cyclosporine or mycophenolate mofetil) for nonadvanced malignancy (1 week for advanced malignancy)

Patient Characteristics:

Age

• Any age

Performance status

• Karnofsky 50-100%

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Not specified

Renal

• Not specified

Expected Enrollment

A total of 5-100 patients will be accrued for this study.

Outcomes

Incidence of life threatening graft-vs-host disease (GVHD)

Disease response
Progression-free and overall survival
Acute and chronic GVHD
Chimerism
Infections

Outline

This is a multicenter, dose-escalation study.

Patients receive unirradiated (viable) donor lymphocyte infusion (DLI) over 15-30 minutes on day 0. Patients may receive a second infusion after 4 weeks if no graft-versus-host disease (GVHD) develops and disease worsens, or after 8 weeks if disease status is unchanged and persistent donor T cells are documented.

To determine the safety of this regimen, all patients receive a standard initial dose of DLI and then, among patients requiring a second treatment, cohorts of 5-25 patients receive decreasing doses of DLI. Acceptable safety is determined by the regimen during which no more than 15% of patients experience morbid GVHD.

Patients are followed every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Brenda Sandmaier, MD, Principal investigator		Ph: 206-667-4961

U.S.A.
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		Brenda Sandmaier, MD	Ph:  206-667-4961
	Seattle Cancer Care Alliance
		Clinical Trials Office - Seattle Cancer Care Alliance	Ph:  800-804-8824
	University of Washington School of Medicine
		Clinical Trials Office - University of Washington School of Medicine	Ph:  206-616-8289
	Veterans Affairs Medical Center - Seattle
		Thomas R. Chauncey, MD, PhD	Ph:  206-762-1010
Wisconsin
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380
Germany
	Leipzig
	Universitaet Leipzig
		Dietger Niederwieser, MD	Ph:  49-341-971-3050
			Email: dietger@medizin.uni_leipzig.de
Italy
	Turin
	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
		Benedetto Bruno, MD, PhD	Ph:  39-339-112-9064
			Email: benedetto.bruno@unito.it

Registry Information
Official Title		Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial
Trial Start Date		2003-05-22
Trial Completion Date		2011-05-22 (estimated)
Registered in ClinicalTrials.gov		NCT00068718
Date Submitted to PDQ		2003-08-04
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CA78902, CA15704

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