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

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With Minimal Differentiation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myelomonocytic Leukemia, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Alkylating Agent-Related Acute Myeloid Leukemia, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Recurrent Adult Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome

In brief

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 with high-risk myelodysplastic syndrome and older patients with acute myeloid leukemia. Giving low doses of chemotherapy, such as busulfan and fludarabine phosphate, before a donor stem cell transplant helps stop the growth of cancer cells. It also stops 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 cells (graft-vs-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving anti-thymocyte globulin before transplant and giving azacitidine, tacrolimus, and methotrexate after the transplant may stop this from happening.

Key facts

Study ID

NCT01168219

Run by

National Cancer Institute (NCI)

People needed

68

Starts

2010-07-15

Expected to finish

2020-02-01

Last updated by the study team

2022-08-04

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• AdventHealth Orlando — Orlando, Florida, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Christiana Care - Union Hospital — Elkton, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Cooper Hospital University Medical Center — Camden, New Jersey, United States
• Northwell Health NCORP — Lake Success, New York, United States
• Northwell Health/Center for Advanced Medicine — Lake Success, New York, United States
• North Shore University Hospital — Manhasset, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• NYP/Weill Cornell Medical Center — New York, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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