NCT02131597

Guadecitabine in Treating Patients With Higher-Risk Myelodysplastic Syndromes

Phase 2 Study of SGI-110 in Patients With Higher Risk MDS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well guadecitabine works in treating patients with myelodysplastic syndromes that are at higher risk for becoming acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the complete response (CR) rate with SGI-110 (guadecitabine) in patients with higher risk myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: I. Overall response rate, survival, transformation to acute myeloid leukemia (AML), transfusion independence. II. Safety and toxicity. OUTLINE: Patients receive guadecitabine subcutaneously (SC) on days 1-5. Treatment repeats every 4-8 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 3 courses are taken off therapy after 6 courses. Patients may continue to receive treatment after 24 courses if the investigator determines it is in the patient's best interest. After completion of study treatment, patients are followed up at 30 days, and then every 2 months.

Conditions

• High Risk Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Guadecitabine	Given SC

Timeline

• Start date: 2014-11-10
• Primary completion: 2024-07-25
• Completion: 2024-07-25
• First posted: 2014-05-06
• Last updated: 2025-07-17
• Results posted: 2025-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study