RecruitingPhase 1Phase 2NCT02392572

ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome

Phase I/II Study of Oral ONC201 in Patients With Relapsed or Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes


Sponsor

M.D. Anderson Cancer Center

Enrollment

120 participants

Start Date

Nov 3, 2015

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial studies the side effects and best dose of ONC201 and to see how well it works in treating patients with acute leukemia or high-risk myelodysplastic syndrome that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). ONC201 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called ONC201 in adults with leukemia or a pre-leukemia blood disorder (called high-risk MDS) whose cancer has come back or stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older - You have acute leukemia or high-risk MDS that has returned or stopped responding to standard therapies - Your kidney, liver, and blood counts are within acceptable limits - Enough time has passed since your last cancer treatment - If you have had a stem cell transplant, it was more than 6 months ago and you have no active graft-versus-host disease **You may NOT be eligible if...** - You have uncontrolled infections, severe heart failure, or uncontrolled irregular heartbeat - You have been treated for another cancer within the past 3 years (except minor skin cancers) - You are known to have HIV, hepatitis B, or hepatitis C - You currently use drugs or alcohol heavily - The leukemia has spread to your brain or spinal fluid - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAkt/ERK Inhibitor ONC201

Given PO

DRUGVenetoclax

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT02392572


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