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Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
NCT06177067 · View on ClinicalTrials.gov ↗
Study Summary
This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug. Primary Objective * To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL. Secondary Objectives * Describe the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and overall survival for patients treated with revumenib + azacitidine + venetoclax at the recommended phase 2 dose (RP2D).
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG Cytarabine
- DRUG Revumenib
- DRUG intrathecal (IT) chemotherapy
Study Locations (10)
Texas
- UT Southwestern/Simmons Cancer Center — Dallas
- Cook Children's Medical Center — Fort Worth
California
- Rady Children's Hospital — San Diego
Colorado
- Children's Hospital Colorado — Aurora
Georgia
- Children's Healthcare of Atlanta — Atlanta
Missouri
- Children's Mercy Hospital of Kansas City — Kansas City
New York
- Memorial Sloan- Kettering Cancer Center — New York
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-04-19 |
| Est. Completion | 2027-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06177067
The ClinicalTrials.gov registry entry for NCT06177067 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 441 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Venetoclax is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06177067 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Texas, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06177067 about?
NCT06177067 is a clinical study titled "Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia". This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after t...
What is the current status of trial NCT06177067?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-04-19. Estimated completion is 2027-04.
What conditions does trial NCT06177067 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Acute Leukemia of Ambiguous Lineage, Relapsed Acute Myeloid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06177067?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Cytarabine (DRUG), Revumenib (DRUG), intrathecal (IT) chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06177067?
This trial is sponsored by St. Jude Children's Research Hospital, which has 441 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06177067 being conducted?
This trial has 10 study locations across California, Colorado, Georgia, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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