Status:
COMPLETED
Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate, and anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in treating patients ...
Detailed Description
PRIMARY OBJECTIVE: I. To determine if this treatment can improve 2-year progression-free survival (PFS) in patients with high risk myelodysplastic syndrome (MDS) and in patients with acute myeloid le...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Meets one of the following sets of criteria:
- Myelodysplastic syndromes (MDS):
- Disease with high-risk features (found either at diagnosis or before initiation of cytotoxic therapy), defined as one of the following:
- International prognostic scoring system (IPSS) risk \>= intermediate-2
- Refractory anemia with excess blasts by French-American-British (FAB) classification
- High-risk cytogenetics (either complex or -7)
- Less than 10% bone marrow blasts as determined by bone marrow biopsy within the past 4 weeks (reduction in marrow blast percentage may be achieved with chemotherapy or other therapy)
- Less than 75 years old
- Acute myeloid leukemia (AML):
- No FAB M3
- No acute leukemia following blast transformation of prior chronic myelogenous leukemia or other myeloproliferative disease
- Patients with preceding MDS or treatment-related AML are eligible
- Prior central nervous system (CNS) involvement is allowed provided the disease is in remission at transplantation
- Morphologic complete remission (leukemia-free state) is defined as meeting all of the following criteria:
- Bone marrow blasts \< 5% (as determined by bone marrow within the past 4 weeks), but without requirement for normal peripheral blood counts
- No extramedullary leukemia
- No blasts in peripheral blood
- Achieved complete remission (CR) after no more than 2 courses of induction chemotherapy
- Patients treated with azacitidine or decitabine who achieve a leukemia-free state are eligible (may have required up to 4 courses of therapy to reach this status)
- Age 60 to 74 years
- Donors must meet the following criteria:
- One of the following:
- HLA-identical sibling (6/6) by serologic typing for class (A, B) and low-resolution molecular typing for class II (DRB1)
- Matched unrelated donor (8/8) by high-resolution molecular typing at HLA-A, -B, -C, and DRB1
- No syngeneic donors
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Calculated creatinine clearance ≥ 40 mL/min
- Bilirubin \< 2 mg/dL OR bilirubin 2-3 mg/dL provided direct bilirubin is normal
- Aspartate aminotransferase (AST) \< 3 times upper limit of normal
- Diffusing capacity of the lung for carbon monoxide (DLCO) \> 40% with no symptomatic pulmonary disease
- Left ventricle ejection fraction (LVEF) \>= 30% by echocardiogram (ECHO) or multigated acquisition (MUGA)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled diabetes mellitus or active serious infections
- No known hypersensitivity to E. coli-derived products, azacitidine, or mannitol
- No human immunodeficiency virus (HIV) infection or active hepatitis B or C
- Prior azacitidine or decitabine allowed
- No patients who progressed from MDS to AML during treatment with azacitidine or decitabine
- At least 4 weeks since prior deoxyribonucleic acid (DNA)-hypomethylating chemotherapy, radiotherapy, and/or surgery
- No more than 2 courses of consolidation therapy before transplantation (for patients with AML)
- Any consolidation regimen that does not require transplantation can be used
- No more than 6 months from documentation of morphologic CR to transplantation
Exclusion
Key Trial Info
Start Date :
July 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01168219
Start Date
July 15 2010
End Date
February 1 2020
Last Update
August 4 2022
Active Locations (17)
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1
Beebe Medical Center
Lewes, Delaware, United States, 19958
2
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
3
AdventHealth Orlando
Orlando, Florida, United States, 32803
4
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242