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NCT02392572 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
120
Enrollment target
1
Study location

NCT02392572: Recruiting Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.

NCT02392572 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 120 participants, above the 45-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (167% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02392572, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
120 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

MTD is defined as the highest dose level in which 6 patients have been treated with at most 1 instance of dose limiting toxicity (DLT). Toxicities defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. DLT defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and occurring during the first cycle on study that meets any of the following criteria

Conditions Studied

Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Refractory Acute Lymphoblastic Leukemia Recurrent Myelodysplastic Syndrome Recurrent Acute Lymphoblastic Leukemia Refractory Myelodysplastic Syndrome

Interventions

  • DRUG Venetoclax
  • DRUG Akt/ERK Inhibitor ONC201

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2015-11-03
Est. Completion 2026-11-30
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What NCT02392572 shows while recruiting

NCT02392572 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 45-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (167% higher).

The record links to 6 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.

NCT02392572 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT02392572 about?

NCT02392572 is a clinical study titled "ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome". 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...

What is the current status of trial NCT02392572?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2015-11-03. Estimated completion is 2026-11-30.

What conditions does trial NCT02392572 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Lymphoblastic Leukemia, Recurrent Myelodysplastic Syndrome, Recurrent Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT02392572?

The interventions under investigation include: Venetoclax (DRUG), Akt/ERK Inhibitor ONC201 (DRUG).

Who is sponsoring clinical trial NCT02392572?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02392572 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Refractory Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02392572's enrollment target sits among peer trials

120 4th of 63 higher than 59 of 63 other Refractory Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT02392572

Source: ClinicalTrials.gov NCT02392572, the US trial registry maintained by the National Library of Medicine. NCT02392572 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.