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| Tracking Information | |||||
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| First Received Date ICMJE | October 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | May 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Treatment-related mortality at 100 days [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Treatment-related mortality at 100 days | ||||
| Change History | Complete list of historical versions of study NCT00025662 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 Peripheral Stem Cell Transplant in Treating Older Patients With Hematologic Cancer | ||||
| Official Title ICMJE | Ex Vivo Selective Depletion of Alloreactive Donor T Lymphocytes Utilizing RFT5-SMPT-dgA, a Specific Anti-Interleukin-2 Receptor Immunotoxin: Reducing Graft-Versus-Host Disease Risk Associated With HLA-Matched, Nonmyeloablative, Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies in Older Adults | ||||
| Brief Summary | RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and removing the T cells from the donor cells before transplant may stop this from happening. PURPOSE: This phase II trial is studying how well fludarabine, melphalan, and donor peripheral stem cell transplant followed by cyclosporin work in treating older patients with hematologic cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and melphalan IV on day -2. Patients undergo infusion of allogeneic T-cell-depleted and CD34-enriched peripheral blood stem cells and selectively depleted lymphocytes on day 0. Patients also receive cyclosporine orally or IV on days -4 to 100 as graft-versus-host disease prophylaxis. Patients may receive unmanipulated or selectively depleted donor lymphocytes on day 100. Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 15-28 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| 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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 28 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | 50 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00025662 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068983, NHLBI-01-H-0162, NCI-5783 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2006 | ||||
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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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