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Tracking Information | |||||
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First Received Date † | November 9, 2004 | ||||
Last Updated Date | March 28, 2009 | ||||
Start Date † | May 2003 | ||||
Current Primary Outcome Measures † |
Life threatening graft-vs-host disease (GVHD) and sustained engraftment [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00096161 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Pentostatin and Donor White Blood Cells in Preventing Graft Rejection in Cancer Patients Who Have Undergone Donor Stem Cell Transplantation | ||||
Official Title † | Pentostatin and Donor Lymphocyte Infusion for Low Donor T-Cell Chimerism After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial | ||||
Brief Summary | RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy or chemotherapy used to kill cancer cells. Infusions of donor white blood cells may decrease the body's rejection of the transplanted peripheral stem cells. Pentostatin, mycophenolate mofetil, and cyclosporine may also prevent this from happening. PURPOSE: This phase I/II trial is studying the side effects of pentostatin and donor white blood cells and to see how well they work in preventing graft rejection in cancer patients who have undergone a donor stem cell transplantation. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients receive pentostatin IV over a few seconds or 20-30 minutes on day -2 and donor lymphocytes IV over 15-30 minutes on day 0. Treatment may repeat once beginning at least 28 days later. Patients are evaluated once 20 patients have been treated. If this regimen is found to be ineffective, subsequent patients receive pentostatin and donor lymphocytes as before, as well as oral cyclosporine twice daily beginning on day -3 and continuing until day 56. Patients also receive oral mycophenolate mofetil once daily beginning on day 0 and continuing until day 27. Patients are followed monthly for 3 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study. |
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Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* 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 † | Recruiting | ||||
Estimated Enrollment † | 80 | ||||
Completion Date | |||||
Estimated Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | up to 74 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Italy | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00096161 | ||||
Responsible Party | Brenda Sandmaier, Fred Hutchinson Cancer Research Center | ||||
Secondary IDs †† | FHCRC-1825.00, SUPERGEN-FHCRC-1825.00 | ||||
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 | February 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |