Study:
A Randomized Phase II Study of Azacitidine in Combination With Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacititdine in Combination With Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Rationale:
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.
Purpose:
This randomized phase II trial studies how well giving azacitidine works with or without
lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes
or chronic myelomonocytic leukemia. 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 Status: Recruiting
Recruiting:
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
Anjali S. Advani 866-223-8100
| Condition |
Intervention |
Phase |
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Previously Treated Myelodysplastic Syndromes
Refractory Anemia With Excess Blasts
Secondary Myelodysplastic Syndromes |
Drug: azacitidine
Drug: lenalidomide
Drug: vorinostat |
Phase 2 |
Verified by
National Cancer Institute (NCI)
April, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT01522976
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio 44122
United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio 44131
United States
Cleveland Clinic Cancer Center-Strongsville
Strongsville, Ohio 44136
United States
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio 44691
United States
Mikkael Sekeres., Principal Investigator