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NCT02392572 · ClinicalTrials.gov record · last posted 2026-08-20

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

StatusTerminated
PhasePhase 1/2
Started2015-11-03
View on ClinicalTrials.gov ↗
Why the trial stopped
\<75% participants
from the ClinicalTrials.gov record
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.

Protocol amendment history 6 changes detected by DataLookout

2026-08-21
Trial terminated
2026-08-21
Trial terminated: \<75% participants
2026-08-21
Primary completion moved earlier: 2026-11-30 → 2026-08-14
2026-08-21
Completion moved earlier: 2026-11-30 → 2026-08-14
2026-08-06
Enrollment closed, study ongoing
2026-08-06
Enrollment reduced: 120 → 58 participants
Trial Details
NCT Number NCT02392572
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Oncoceutics, Inc.
Conditions Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Myelodysplastic Syndrome
Enrollment 58 participants
Start Date 2015-11-03
Primary Completion 2026-08-14 (estimated)
Study Completion 2026-08-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-20