Study on Azacitidine With or Without Lenalidomide or Vorinostat for Treating Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

Program Overview

The purpose of this study is to determine if azacitidine, a chemotherapy drug, works better alone or when combined with lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). Azacitidine helps stop cancer cells from growing, while lenalidomide may block blood flow to cancer cells, and vorinostat may block enzymes needed for cancer cell growth. The study aims to find out which combination is most effective in controlling these diseases.

Description

This study is divided into two phases. In Phase II, researchers will compare the effectiveness of azacitidine combined with either lenalidomide or vorinostat against azacitidine alone. The goal is to see which combination leads to better responses, such as complete or partial remission or improvement in blood counts. In Phase III, the best combination from Phase II will be tested further to compare overall survival rates against azacitidine alone.

Secondary goals include estimating how long patients remain free from disease relapse, overall survival rates, and the response of cancer cells to treatment. The study will also look at the side effects of each treatment and collect samples for future research.

Patients will be randomly assigned to one of three treatment groups. In Phase III, they will be assigned to one of two groups: the best combination from Phase II or azacitidine alone.

• Group 1: Azacitidine and lenalidomide
• Group 2: Azacitidine alone
• Group 3: Azacitidine and vorinostat

Treatment cycles repeat every 28 days for up to 5 years unless the disease progresses or side effects become unacceptable. After treatment, patients will have follow-up visits every 3 months for up to 5 years.

Eligibility Criteria

Locations