Clinical Trial ECOGHEMS1117
A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) Vs. Azacitidine Alone Vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
- Protocol No. ECOGHEMS1117
- Open Date: 09/10/2013
- Staging: Phase II
- Age Group: Adults
- Scope: National
- Objective: To test whether the response rate (complete remission, partial remission, or hematologic improvement) of patients with higher-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) who receive either the combination of lenalidomide and azacitidine or the combination of vorinostat and azacitidine is improved compared to patients who receive single-agent azacitidine.
- Disease Sites: Leukemia
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Azacitidine; Lenalidomide; Vorinostat (ZOLINZA)
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: 01802333
- Secondary Protocol No: S1117
The purpose of this study is to compare the effects, good and/or bad on higher risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML), of adding either the drug lenalidomide or the drug vorinostat to the regular treatment drug azacitidine, (e.g. the addition of lenalidomide or vorinostat to standard therapy using azacitidine is investigational). In this study, participants will be on one of the following treatment arms: azacitidine alone, azacitidine and lenalidomide or azacitidine and vorinostat. Participants will only get one of these treatments. People are being asked to take part in this study because they have a higher risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). This means that their bone marrow does not create enough of at least one type of blood cell that their body needs.