CALGB 11002 - A Randomized Phase II Trial of Decitabine-Based Induction Strategies for Patients ≥ 60 Years Old With Acute Myeloid Leukemia (AML)

Study Status

Open to Enrollment

Study Description

The purpose of this study is to determine if treating older patients with acute myeloid leukemia (AML) with decitabine plus bortezomib significantly improves their response compared with decitabine alone. This treatment is a lower intensity chemotherapy than the standard chemotherapy treatment for AML. The standard chemotherapy for AML is not very successful in older patients, requiring prolonged hospitalization; it is often felt to be too difficult for older patients.

Decitabine has been approved by the FDA for the treatment of myelodysplastic syndrome. Decitabine has helped some patients with AML by producing a complete remission, but it is not yet known how decitabine compares to standard chemotherapy treatment. Bortezomib has been FDA approved for treating multiple myeloma. Preliminary studies indicate that bortezomib may be helpful in AML when combined with decitabine.
Patients will be randomly assigned to one of two study groups:
  • Group A: Patients will receive decitabine
  • Group B: Patients will receive decitabine and bortezomib

 

Disease Status and/or Stage

Acute Myeloid Leukemia

Sponsor

CALGB

Key Eligibility

  • Men and women age 60 and older
  • Acute Myeloid Leukemia (AML)
  • No prior treatment for AML
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Gail Roboz, MD

Contact

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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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