NCT05326516

A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia

AUGMENT-102: A Phase 1, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability and Preliminary Anti-Leukemic Activity of SNDX-5613 in Combination With Chemotherapy in Patients With Relapsed/Refractory Leukemias Harboring Alterations in KMT2A/MLL, Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 30 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and tolerability of revumenib when given in combination with 2 different chemotherapy regimens in participants with relapsed/refractory acute leukemias harboring KMT2A rearrangement, KMT2A amplification, NPM1c, or NUP98r.

Conditions

• Relapsed/Refractory Leukemias
• Acute Lymphoblastic Leukemia
• Acute Lymphocytic Leukemia
• Mixed Phenotype Acute Leukemia
• Acute Myeloid Leukemia
• Acute Undifferentiated Leukemia

Interventions

Type	Name	Description
DRUG	Revumenib	Participants will receive revumenib until meeting criteria for discontinuation.
DRUG	Chemotherapy Regimen 1	Participants will receive 2 treatment cycles of chemotherapy. During Cycle 1, participants will receive prednisone, vincristine, pegaspargase/calaspargase pegol-mknL, and daunorubicin. During Cycle 2, participants will receive etoposide and cyclophosphamide.
DRUG	Chemotherapy Regimen 2	Participants will receive 2 treatment cycles of chemotherapy. During Cycles 1 and 2, participants will receive fludarabine and cytarabine.

Timeline

• Start date: 2022-03-09
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2022-04-13
• Last updated: 2024-08-13

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study