S1117: A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat for Higher-Risk Myelodysplatic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with higher risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).

The purpose of the study is to compare the effectiveness of adding either the drug lenalidomide or the drug vorinostat to the regular drug azacitidine in treating MDS or CMML.

Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with or without lenalidomide or vorinostat in treating myelodysplastic syndromes or chronic myelomonocytic leukemia.

Study participants will be randomly assigned to one of three treatment arms:

Arm 1: Azacitidine and lenalidomide

  • Azacitidine via injection or infusion Days 1-7 of a 28-day cycle
  • Lenalidomide capsule by mouth once a day Days 1-21 of a 28-day cycle

Arm 2: Azacitidine alone

  • Azacitidine via injection or infusion Days 1-7 of a 28-day cycle

Arm 3: Azacitidine and vorinostat

  • Azacitidine via injection or infusion Days 1-7 of a 28-day cycle
  • Vorinostat capsule my mouth on Days 3-9 of a 28-day cycle

Participants will take the study medication(s) for as long as they are responding to treatment.

Disease Status and/or Stage

Higher Risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)

Sponsor

CALGB

Key Eligibility

  • Men and women age 18 and older
  • Higher risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
  • Must not have received prior treatment with lenalidomide, azacitidine, vorinostat or decitabine
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Gail Roboz, MD

Contact

Protocol ID

S1117

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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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