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Azacitidine With or Without Lenalidomide or Vorinostat in Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

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) September, 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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