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Tracking Information | |||||
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First Received Date † | January 24, 2003 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | September 2002 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00052520 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 † | Biological Therapy in Treating Patients With Advanced Acute or Chronic Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation | ||||
Official Title † | Phase I/II Study Of Adoptive Immunotherapy With CD8+ WT1-Specific CTL Clones for Patients With Advanced MDS, CML, AML or ALL After Allogeneic Hematopoietic Stem Cell Transplant | ||||
Brief Summary | RATIONALE: Biological therapies work in different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells in patients undergoing donor stem cell transplantation. PURPOSE: This phase I/II trial is studying the side effects of biological therapy and to see how well it works in treating patients with advanced chronic myeloid leukemia, acute myeloid leukemia, or acute lymphoblastic leukemia. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a pilot study. Donors undergo leukapheresis for stem cell harvest to generate CD8-positive Wilms' tumor (WT1) gene-specific cytotoxic T-lymphocyte (CTL) clones at the time of allogeneic stem cell transplantation. After post-transplantation hematopoietic recovery, patients receive treatment for either highest-risk disease (prophylactically) or relapsed disease.
Patients receive interleukin-2 subcutaneously twice daily on days 28-42 in the absence of unacceptable toxicity.
Patients in both groups who have progressive disease after complete or partial response to therapy may be eligible for retreatment with CD8-positive Wilms' tumor (WT1) gene-specific CTL clones. Blood samples may be collected monthly and patients may undergo a bone marrow biopsy every 3 months. Samples are analyzed for WT1 specific T cells via multimer staining and flow cytometric analysis; functional anti-WT1 activity; other immunological parameters; WT 1 expression; and potential genetic markers. In addition samples may be assessed by morphology, flow cytometry, PCR or cytogenetic analysis. After completion of study treatment, patients are followed for up to 2 years. PROJECTED ACCRUAL: A total of 10-15 patients will be accrued for this study within 3-5 years. |
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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 |
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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 | ||||
Enrollment † | 15 | ||||
Completion Date | |||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | up to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00052520 | ||||
Responsible Party | Gunnar Ragnarsson, Fred Hutchinson Cancer Research Center | ||||
Secondary IDs †† | FHCRC-1655.00 | ||||
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. |