A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
A Phase 2 Study of Revumenib (SNDX-5613) in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia
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Clinical Trial Information
Trial Contact: Armatti, Julie M; Parker, Melanie; Torrescano, Tanner; Frankos, Marie; Jones, Jamie; Singh, Sarah H
Trial Phone: 321-843-5284 ; 321-843-1036 ; 321-841-8271 ; 321-842-8738 ; 3218412008 ; 321.841.7561
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IRB No: AALL2121
Protocol Abbrev: AALL2121
Principal Investigator: Jaime C Gonzalez, MD
Phase: Drug: Phase II
Age Group: Pediatric
Secondary Protocol No: AALL2121
Treatment: Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Drug: Calaspargase Pegol, Drug: Cytarabine, Procedure: Echocardiography, Drug: Fludarabine Phosphate, Drug: Hydrocortisone Sodium Succinate, Procedure: Lumbar Puncture, Drug: Methotrexate, Procedure: Multigated Acquisition Scan, Drug: Prednisolone, Drug: Prednisone, Drug: Revumenib, Drug: Vincristine Sulfate
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05761171
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Objective
To determine the recommended phase 2 dose (RP2D) of revumenib administered in combination with chemotherapy in patients with relapsed or refractory (R/R) KMT2A-rearranged (KMT2A-R) acute lymphoblastic leukemia (ALL).
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Key Eligibility
Patients must be 1 month to < 6 years old at the time of study enrollment and must have had initial diagnosis of leukemia at < 2 years old.
