CALGB 100801: Phase II Study of the Addition of Azacitidine to Reduced-Intensity Conditioning Allogeneic Transplantation for Myelodysplasia (MDS) and Older patients With AML

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with acute myeloid leukemia (AML) or myelodysplasia (MDS).

People with MDS and older patients with AML do not do well with standard therapies. The use of azacitidine has been shown to be beneficial in treating MDS and AML. This study is being done to see if the benefit of an allogeneic transplant can be improved by providing ongoing treatment with azacitidine after a successful transplant with the hope of achieving longer remission.

The study will evaluate giving busulfan, fludarabine phosphate, and antithymocyte globulin followed by donor stem cell transplant and treatment with azacitidine. 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 antithymocyte globulin before transplant and giving azacitidine, tacrolimus, and methotrexate after the transplant may stop this from happening.

Azacitidine is FDA approved for AML and MDS but it is not normally given after transplantation; therefore its use in this study is experimental.

Between 42 and 90 days after transplant, participants will receive azacitidine via infusion once daily for 5 days every 4 weeks (each treatment cycle is 4 weeks) for up to 6 cycles of azacitidine.  

Disease Status and/or Stage

Acute Myeloid Leukemia and Myelodysplasia



Key Eligibility

  • Acute Myeloid Leukemia (AML)
    • Men and women ≥ age 60 and < age 75
  • Myelodysplasia (MDS
    • Men and women < age 75 with high risk MDS
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Tsiporah Shore, M.D.


Protocol ID

CALGB 100801

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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