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| Descriptive Information Fields | |||||
| Brief Title † | Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation | ||||
| Official Title † | Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial | ||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | Incidence of life threatening graft-vs-host disease (GVHD) [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | 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: No ] Chimerism [ Designated as safety issue: No ] Infections [ Designated as safety issue: No ] |
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| Condition † | 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 |
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| Intervention † | Drug: therapeutic allogeneic lymphocytes | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 100 | ||||
| Start Date † | May 2003 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Germany, Italy | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00068718 | ||||
| Organization ID | CDR0000327819 | ||||
| Secondary IDs †† | FHCRC-1803.00 | ||||
| Study Sponsor † | Fred Hutchinson Cancer Research Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2008 | ||||
| First Received Date † | September 10, 2003 | ||||
| Last Updated Date | October 8, 2008 | ||||