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Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation
This study is currently recruiting participants.
Study NCT00068718   Information provided by National Cancer Institute (NCI)
First Received: September 10, 2003   Last Updated: July 7, 2009   History of Changes

September 10, 2003
July 7, 2009
May 2003
May 2011   (final data collection date for primary outcome measure)
Incidence of life threatening graft-vs-host disease (GVHD) [ Designated as safety issue: Yes ]
Incidence of life threatening graft-vs-host disease (GVHD)
Complete list of historical versions of study NCT00068718 on ClinicalTrials.gov Archive Site
  • Disease response [ Designated as safety issue: No ]
  • Progression-free and overall survival [ Designated as safety issue: No ]
  • Acute and chronic GVHD [ Designated as safety issue: Yes ]
  • Chimerism [ Designated as safety issue: No ]
  • Infections [ Designated as safety issue: Yes ]
  • Disease response
  • Progression-free and overall survival
  • Acute and chronic GVHD
  • Chimerism
  • Infections
 
Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation
Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial

RATIONALE: White blood cells from donors may be able to kill cancer cells and prevent disease progression or relapse in patients who have undergone allogeneic bone marrow transplantation or allogeneic stem cell transplantation.

PURPOSE: This phase I/II trial is studying the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent, relapsed, or progressing cancer after allogeneic bone marrow transplantation or stem cell transplantation.

OBJECTIVES:

Primary

  • 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

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

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.

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

Phase I, Phase II
Interventional
Treatment
  • Chronic Myeloproliferative Disorders
  • Graft Versus Host Disease
  • Kidney Cancer
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Neuroblastoma
  • Ovarian Cancer
  • Sarcoma
  • Testicular Germ Cell Tumor
Biological: therapeutic allogeneic lymphocytes
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
 
May 2011   (final data collection date for primary outcome measure)

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

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Karnofsky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Not specified

Renal

  • Not specified

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)
Both
 
No
 
United States,   Germany,   Italy
 
NCT00068718
Brenda Sandmaier, Fred Hutchinson Cancer Research Center
CDR0000327819, FHCRC-1803.00
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Brenda Sandmaier, MD Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP