NCT06085638

Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myelomonocytic Leukemia

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if adding venetoclax to the chemotherapy combination of tamibarotene and azacitidine is more effective than tamibarotene and azacitidine alone in treating higher-risk CMM

Detailed description

Primary Objectives: * Cohort 1: Characterize the safety and toleratbility of the combination of azacitidine and tamibarotene in newly diagnosed CMML. * Cohort 2 and 3: Characterize the safety and tolerability of tamibarotene in combination with azacitidine and venetoclax in relapsed higher risk CMML. Secondary Objectives: * Cohort 1: Characterize the preliminary clinical activity of tamibarotene in combination with azacitidine defined by complete response (CR) rate, following MDS/MPN IWG response criteria (Appendix 1), * Cohort 2: Characterize the safety and tolerability of tamibarotene in combination with azacitidine and venetoclax in relapsed higher risk CMML. * Cohort 3: Characterize the clinical activity of tamibarotene in combination with azacitidine and venetoclax by overall response rate (ORR) in relapsed higher risk CMML. * To characterize additional clinical activity outcomes such as duration of response, leukemia-free survival (LFS), event-free survival (EFS) and overall survival (OS). * To evaluate differences in response and efficacy outcomes by MDS/MPN IWG response criteria based on RARA expression levels and positivity. * To correlate response with disease subtype and genomic profile * To evaluate changes in clonal composition and VAF of identified mutations with therapy.

Conditions

• Chronic Myelomonocytic Leukemia

Interventions

Type	Name	Description
DRUG	Azacitidine	Given by SC (under the skin) or IV (vein)
DRUG	Tamibarotene	Given by PO
DRUG	Venetoclax	Given by PO TAMIBAROTENE Azacitidine Azacitidine, 5-azacytidine, 5-aza, Vidaza™, 5-AZC, AZA-CR, Ladakamycin, NSC-102816, Azacytidine Venetoclax ABT-199, GDC-0199, Venetoclax

Timeline

• Start date: 2023-09-14
• Primary completion: 2023-10-20
• Completion: 2023-10-20
• First posted: 2023-10-17
• Last updated: 2024-03-07

Regulatory

• FDA-regulated drug study