NCT04734990

Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Phase I/II Study of SP-2577 (Seclidemstat) in Combination With Azacitidine for Patients With Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial identifies the best dose of seclidemstat when given together with azacitidine in treating patients with myelodysplastic syndrome or chronic myelomonocytic leukemia. Seclidemstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine may help block the formation of growths that may become cancer. Giving seclidemstat and azacytidine may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety, tolerability and maximum tolerable dose (MTD) of seclidemstat in combination with azacitidine. II. To assess overall response rate (ORR) to seclidemstat in combination with azacitidine. SECONDARY OBJECTIVES: I. To assess overall survival (OS), duration of response (DOR), relapse-free survival (RFS), and leukemia-free survival (LFS) and safety profile. II. Correlative studies including correlation of response with disease subtypes, genomic profile and in vitro studies. OUTLINE: This is a phase I, dose-escalation study of seclidemstat followed by a phase II dose-expansion study. Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) on days 1-7. Patients also receive seclidemstat orally (PO) once daily (QD) on day 1 of cycle 1 and PO twice daily (BID) on days 2-28 of cycle 1 and on days 1-28 of all subsequent cycles. There are 6 possbile dose levels for seclidemstat: 300 mg, 450 mg, 600 mg, 900 mg, 1200 mg and 1500 mg. Successive cohorts of eligible patients will be treated with azacitidine until the phase 2 recommended dose or maximum tolerated dose is determined. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days, and then every 6 months thereafter

Conditions

• Chronic Myelomonocytic Leukemia-0
• Chronic Myelomonocytic Leukemia-1
• Chronic Myelomonocytic Leukemia-2
• Myelodysplastic Syndrome
• Recurrent Chronic Myelomonocytic Leukemia
• Recurrent Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Azacitidine	Given IV or SC
DRUG	Seclidemstat	Given PO

Timeline

• Start date: 2021-07-07
• Primary completion: 2027-09-11
• Completion: 2027-09-11
• First posted: 2021-02-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study