NCT00732316CompletedPhase 2
HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING OF BUSULFAN, FLUDARABINE, AND ANTI-THYMOCYTE GLOBULIN FOR ADULT PATIENTS WITH HEMATOLOGIC MALIGNANCIES AND MYELODYSPLASTIC SYNDROME - A PHASE 2 STUDY
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- tumor response
Study Overview
Brief Summary
RATIONALE: Giving low doses of chemotherapy and antithymocyte globulin before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer and abnormal cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works after busulfan, fludarabine, and antithymocyte globulin in treating patients with hematologic cancer or myelodysplastic syndrome.
Detailed Description
OBJECTIVES:
- To evaluate the efficacy of HLA-haploidentical familial donor hematopoietic cell transplantation with a reduced-intensity conditioning regimen of busulfan, fludarabine phosphate, and anti-thymocyte globulin in patients with hematologic malignancies or myelodysplastic syndromes.
OUTLINE: Before receiving the reduced-intensity conditioning regimen, patients receive one dose of intrathecal (IT) methotrexate, then leucovorin calcium IV or orally 4 hours after methotrexate and every 6 hours for a total of 8 doses.
- Reduced-intensity conditioning regimen: Patients receive busulfan IV over 6 hours on days -7 and -6, fludarabine phosphate IV over 30 minutes on days -7 to -2, anti-thymocyte globulin (ATG) IV over 4 hours on days -4 to -1, and methylprednisolone IV over 30 minutes on days -4 to -1.
- HLA-haploidentical familial donor hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT over 1 hour on days 0 and 1.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV* over 2-4 hours every 12 hours on days -1 to 30 followed by a taper until day 60 and methotrexate IV on days 2, 4 , 7, and 12.
NOTE: *Cyclosporine can be given orally once oral medication can be tolerated
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following hematological malignancies:
- •Acute leukemia, including any of the following:
- •Refractory acute leukemia
- •Acute leukemia beyond first remission
- •Acute leukemia in first remission with intermediate to poor prognostic features as suggested by chromosomal findings
- •Chronic myelogenous leukemia (CML)
- •Second chronic phase
- •Accelerated phase
- •Blastic phase
- •Myelodysplastic syndrome (MDS)
- •High-risk MDS (refractory anemia with excess blasts [RAEB], RAEB in transformation, and chronic myelomonocytic leukemia) can be transplanted without prior therapy or after prior therapy failure with hypomethylating agents
- •Low-risk MDS can be considered for transplantation after prior therapy failure with immunosuppressive or hypomethylating agents
- •No willing, suitable HLA-matched donor in family or in donor registries
- •Patients with active hematologic malignancy, who are felt to be in urgent need of allogeneic hematopoietic cell transplantation, can enroll without a search for HLA-matched unrelated donors
- •Related donor with HLA-haploidentical mismatch at 3 or less of 6 loci available
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •Bilirubin < 2.0 mg/dL
- •Creatinine < 2.0 mg/dL
- •AST < 3 times upper limit of normal
- •Ejection fraction > 40% by MUGA
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
tumor response
Time Frame: about 4-8 weeks after transplantation
leukemia CR, CR duration
Secondary Outcomes
- Donor cell engraftment (neutrophil, platelet, and red blood cells)(10-35 days after transplantation)
- Acute and chronic graft-versus-host disease(15-100 days; 100 days to 4 years)
Investigators
Kyoo-Hyung Lee
Professor of Internal Medicine
Asan Medical Center
Study Sites (1)
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