Cancer

Title
A Study Evaluating the Efficacy of Combining Azacitidine With Lenalidomide or Vorinostat as Compared to Azacitidine Alone for Higher-risk MDS and CMML Subjects.
Trial Number
204408051612
Number of Participants
267
Principal Investigator
Eligibility

Participants must be 18 years or older. Participants must have morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) based on one of the following:
FAB: Refractory anemia with excess blasts (RAEB – defined as having 5- 20 percent myeloblasts in the bone marrow); Chronic Myelomonocytic Leukemia (CMML) with 10-19 percent myeloblasts in the bone marrow and/or 5-19 percent blasts in the blood. WHO: Refractory anemia with excess blasts-1 (RAEB-1 – defined as having 5-9 percent myeloblasts in the bone marrow); refractory anemia with excess blasts-2 (RAEB-2 – defined as having 10- 19 percent myeloblasts in the bone marrow and/or 5-19 percent blasts in the blood); Chronic Myelomonocytic Leukemia-1 (CMML-1 – defined as having

Participants must not have used or be using HDAC inhibitor agents for anticancer treatment.

Purpose

The purpose of this study is to compare the effects, good and/or bad on, of adding either the drug lenalidomide or the drug vorinostat to the regular treatment drug azacitidine in participants who have high risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). Participants in this study will be on one of the following treatment arms: azacitidine alone, azacitidine and lenalidomide or azacitidine and vorinostat.

Enrollment

(708) 327-3317

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