BENITIONSClinical Trial Intelligence

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

Phase 2 Active, not recruiting NCT01522976

ConditionChronic Myelomonocytic Leukemia, Chronic Myelomonocytic Leukemia-1, Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome
PhasePhase 2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment282 participants
InterventionsAzacitidine, Laboratory Biomarker Analysis, Lenalidomide, Vorinostat
Start dateMar 1, 2012
Completion dateJun 1, 2015
Results postedMar 22, 2016

Summary

This randomized phase II/III trial studies how well 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, stopping them from dividing, or by stopping them from spreading. 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.

Response Rate (Phase II)

Up to 5 years · percentage of patients having a response

Arm 1: Azacitidine/Lenalidomide49 percentage of patients having a response
Arm 2: Azacitidine38 percentage of patients having a response
Arm 3: Azacitidine/Vorinostat27 percentage of patients having a response

Overall Survival (Phase III)

Up to 5 years

Open in BENITIONS View on ClinicalTrials.gov

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