A Phase IIB Study of 5-Azacitidine with or without Panobinostat in Patients with Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Acute Myeloid Leukemia

Protocol
12-219
Full Title
A Phase Ib/IIb, Open-label, Multi-center Study of Oral Panobinostat (LBH589) Administered with 5-Azacitidine (Vidaza®) in Adult Patients with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myeloid Leukemia (AML)
Purpose

5-Azacitidine is a standard chemotherapy drug used to treat myelodysplastic syndromes (MDS) and leukemia. In this study, researchers want to determine if giving the investigational drug panobinostat with 5-azacitidine is more effective than 5-azacitidine alone for inducing remission or slowing disease progression in patients with MDS, chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML).

Panobinostat is a drug called a histone deacetylase inhibitor (HDAC), which prevents cancer cells from reproducing by interfering with certain signaling pathways. Patients will be randomly assigned to receive panobinostat with 5-azacitidine or 5-azacitidine alone. 5-azacitidine is given via injection, while panobinostat is given as a capsule.

Investigator
Virginia M. Klimek, MD
Virginia M. Klimek - Physician Profile
Co-Investigators
Stephen S. Chung, MD
Stephen S. Chung - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have MDS, CMML, or AML and may not be scheduled for stem cell transplantation.
  • MDS must be intermediate or high-risk and not therapy-related. AML may not be therapy-related, nor relapsed or refractory to other therapies.
  • Patients may not have had prior treatment with an HDAC drug, 5-azacitidine, or decitabine.
  • With the exception of hydroxyurea, all prior treatment must have been completed at least 4 weeks before entering the study (hydroxyurea can be taken up to 24 hours before starting the study drug).
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients ages 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Virginia Klimek at 212-639-6519.

Disease(s)
Leukemia
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Leukemia: Chronic Myelocytic Leukemia
Leukemia: Myelodysplastic Syndrome
Locations
Related Diseases

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