Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
132

Summary

Conditions
  • Acute Leukemia of Ambiguous Lineage
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Mixed Lineage Acute Leukemia
  • Mixed Phenotype Acute Leukemia
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: Phase 1 will employ an accelerated titration design. The dose escalation will follow a modified Fibonacci sequence.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

Phase 1 dose escalation will determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of SNDX-5613 in patients with acute leukemia harboring an MLL rearrangement or NPM1 mutation: Arm A: Patients not receiving any strong cytochrome P450 3A4 (CYP3A4) inhibitor/ inducers. Arm B:...

Phase 1 dose escalation will determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of SNDX-5613 in patients with acute leukemia harboring an MLL rearrangement or NPM1 mutation: Arm A: Patients not receiving any strong cytochrome P450 3A4 (CYP3A4) inhibitor/ inducers. Arm B: Patients receiving strong cytochrome P450 3A4 (CY3A4) inhibitors for antifungal prophylaxis. Arm C: Patients receiving SNDX-5613 in combination with cobicistat. In Phase 2, patients will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of SNDX-5613: Cohort 2A: Patients with MLLr acute lymphoblastic leukemia (ALL)/mixed phenotype acute leukemia (MPAL). Cohort 2B: Patients with MLLr AML. Cohort 2C: Patients with NPM1c AML.

Tracking Information

NCT #
NCT04065399
Collaborators
Not Provided
Investigators
Study Director: Galit Rosen, M.D. Syndax Pharmaceuticals, Inc.
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