A Phase I Study of SNDX-5613 with Chemotherapy for People with Fast-Growing Leukemia

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Full Title

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 a KMT2A/MLL Gene Rearrangement or Nucleophosmin 1 Mutation (mNPM1)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug SNDX-5613 when given with standard chemotherapy in children and adults with fast-growing leukemia that has come back or continued to grow despite treatment and contains certain genetic mutations. SNDX-5613 is designed to block a protein called menin, which is required for cells to divide. By blocking this protein, SNDX-5613 may prevent cancer cells from growing. SNDX-5613 is taken orally (by mouth) and can also be given through a nasogastric or g-tube (a tube inserted down the nose into the stomach).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have fast-growing leukemia that has come back or continued to grow despite prior treatment.
  • Patients’ leukemia must contain a mutation in the KMT2A/MLL and/or the NPM1 gene.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 30 days and older.

Contact

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

22-239

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators