Status:
TERMINATED
Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
14-55 years
Phase:
PHASE2
Brief Summary
RATIONALE: Allogeneic hematopoietic stem cell transplant (HSCT) is a treatment that can cure acute leukemia and myelodysplasia. After giving the patient chemotherapy and total body irradiation to stop...
Detailed Description
OBJECTIVES: Primary * Estimate the probability of grades II-IV acute graft-vs-host disease (GVHD) in patients with acute leukemia or advanced myelodysplastic syndromes treated with CD45RA+ T-cell-de...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) in first or subsequent remission
- ALL or AML in relapse or primary refractory ALL or AML with a circulating blast count ≤ 10,000/mm\^3
- Refractory anemia with excess blasts (RAEB) (RAEB-1 or RAEB-2) if the patient has received induction chemotherapy within the past 60 days
- Appropriate candidate for allogeneic hematopoietic stem cell transplantation (HSCT)
- No CNS involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiotherapy
- PATIENT CHARACTERISTICS:
- Age 14-55
- Creatinine \< 1.5 mg/dL
- Cardiac ejection fraction \> 45%
- DLCO corrected \> 60% of predicted
- Total bilirubin \< 2 times upper limit of normal (ULN) (unless attributed to Gilbert syndrome)
- AST and ALT \< 2 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 12 months after transplantation
- HIV negative
- No co-existing disease (other than leukemia or RAEB) that would limit life expectancy to \< 3 months
- No uncontrolled infection that, in the opinion of the consulting infectious disease physician, would contraindicate myeloablative HSCT
- No other medical condition that would contraindicate HSCT
- No known hypersensitivity to tacrolimus
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior HSCT
- No concurrent participation in other experimental studies for the prevention of graft-vs-host disease
- DONOR CHARACTERISTICS:
- Genotypic or phenotypic HLA-identical related donor
- Able to donate peripheral blood stem cells
- Age \> 14 years
- Applicable to male patients only: No female donors who have previously given birth to a male child or have had a pregnancy beyond the first trimester miscarriage or termination of pregnancy or nursing
- No donors who have received blood transfusions
- No CD45 Mutation with aberrant CD45RA isoform expression
Exclusion
Key Trial Info
Start Date :
December 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2020
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00914940
Start Date
December 17 2009
End Date
May 26 2020
Last Update
August 20 2020
Active Locations (2)
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1
Yale University School of Medicine/Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
2
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024