SNDX-5613 with chemotherapy in newly diagnosed AML patients
Research type
Research Study
Full title
A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes
IRAS ID
1010778
Contact name
Jessica Clement
Contact email
Sponsor organisation
Syndax Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
Acute myeloid leukaemia (AML) is a rare, aggressive cancer of the white blood cells. Around 3,100 people are diagnosed each year in the UK. Intensive chemotherapy is the standard treatment and leads to remission in most patients. However, 40% of patients relapse after consolidation therapy (further treatment to remove any remaining cancer cells).
This study aims to determine the safety, tolerability, and recommended dose of revumenib (SNDX-5613) for future studies when combined with intensive chemotherapy and given alone as maintenance therapy.
Eligible participants are adults who have recently been diagnosed with AML, with a specific genetic rearrangement, and have not yet received any treatment. The study includes 3 phases starting with a screening period that can last up to 18 days:
• Induction (1 or 2 courses): Intensive chemotherapy continuously from Day 1-8, with revumenib tablets taken orally twice daily from Day 8-28. Eleven study visits will occur.
• Consolidation (up to 4 cycles): Six doses of chemotherapy over 3-5 days, with revumenib taken twice daily from Day 6-26. Nine study visits per cycle.
• Maintenance: Revumenib taken until disease progression, participant withdrawal, or study end. Study visits will take place every 28 days.Study procedures include physical examinations, vital signs, ECG, ECHO or MUGA scans of the heart, blood, urine and bone marrow samples and eye examinations.
Duration of participation is based on the number of cycles received, how well revumenib works for the participant and any possible side effects.
An end of treatment visit will occur within 7 days of the last dose of revumenib, followed by another visit about 30 days later. Patients will then have monthly follow-up telephone calls for the first 12 months and then every 90 days after that.
This study is sponsored by Syndax Pharmaceuticals, Inc. Approximately 76 patients will participate in this study worldwide with around 6 patients from the UK.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0236
Date of REC Opinion
4 Dec 2024
REC opinion
Further Information Favourable Opinion