Study of Rebecsinib for Relapsed/Refractory Secondary AML or High-Risk Myelofibrosis
This study is testing a new investigational drug called rebecsinib to find the safest and most effective dose. You may be able to join if you have Secondary Acute Myeloid Leukemia (sAML) that has come back or not responded to previous treatments, or if you have high-risk Myelofibrosis (MF). Participants will receive rebecsinib through an IV on specific days during each 28-day cycle, for up to 6 cycles. The main goals are to determine the highest safe dose of rebecsinib and to understand its safety and any side effects. The study plans to enroll about 28 people.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll about 28 participants.
- What's involved
- You would receive rebecsinib by IV infusion on Days 1, 4, 8, and 11 of each 28-day cycle, for a total of 6 cycles. Safety will be monitored for approximately 4 months after enrollment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will monitor for adverse events from enrollment until you start a new therapy, which is approximately 4 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of Rebecsinib for Patients With Relapsed/Refractory Secondary Acute Myeloid Leukemia or High Risk Myelofibrosis
At a glance
Conditions
Where it's being run
3 sites across 1 statesStudy leadership
- James Mangan, MD, PhD · PRINCIPAL_INVESTIGATOR · UC San Diego Moores Cancer Center
Who to contact
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What this trial measures
- Determine the Maximum Tolerated DoseFrom first dose through 28 days after initial dose for dose all finding cohorts, approximately 2 years.
Find the rate of dose limiting toxicities (DLTs) to establish the maximum tolerated dose (MTD) or biologically active dose of rebecsinib when given on days 1, 4, 8, and 11 of each 28 days cycle.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]From enrollment to initiation of new therapy for each subject, approximately 4 months.
To determine the safety and tolerability of rebecsinib by ongoing evaluation of treatment-emergent adverse events (AEs) by collecting description, timing, grade \[CTCAE v5.0\], severity, seriousness, and relatedness of all events.