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| Tracking Information | |||||
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| First Received Date ICMJE | September 10, 2003 | ||||
| Last Updated Date | July 7, 2009 | ||||
| Start Date ICMJE | May 2003 | ||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Incidence of life threatening graft-vs-host disease (GVHD) [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Incidence of life threatening graft-vs-host disease (GVHD) | ||||
| Change History | Complete list of historical versions of study NCT00068718 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation | ||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Biological: therapeutic allogeneic lymphocytes | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 ICMJE | |||||
| Location Countries ICMJE | United States, Germany, Italy | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00068718 | ||||
| Responsible Party | Brenda Sandmaier, Fred Hutchinson Cancer Research Center | ||||
| Study ID Numbers ICMJE | CDR0000327819, FHCRC-1803.00 | ||||
| Study Sponsor ICMJE | Fred Hutchinson Cancer Research Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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