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Clinical Trial Detail

Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs

Complete title: A Phase 3, Multicenter, Randomized, Open-label Study of Guadecitabine (SGI-110) versus Treatment Choice in Adults with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated with Hypomethylating Agents

Research Study Number 9723
 
Principal Investigator Bart Scott, MD
 
Phase III

Research Study Description

A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in subjects with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 subjects from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 subjects) or Treatment Choice (approximately 136 subjects). The study consists of a 14-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual subject participation will vary. Subjects may continue to receive treatment for as long as they continue to benefit.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.

Research Study Number 9723
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Hematologic Malignancies; Leukemia; Myelodysplastic Syndromes (MDS); Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Chronic Myelomonocytic (CMML); Preleukemia; Bone Marrow Diseases

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