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

    Not Recruiting
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 21 September 2023
chronic myelomonocytic leukemia
granulocyte colony stimulating factor
colony stimulating factor
myelomonocytic leukemia


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.



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.


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

Condition Chronic Myelomonocytic Leukemia-0, Chronic Myelomonocytic Leukemia-1, Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic Syndrome
Treatment Azacitidine, Seclidemstat
Clinical Study IdentifierNCT04734990
SponsorM.D. Anderson Cancer Center
Last Modified on21 September 2023

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