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NCT06177067 · ClinicalTrials.gov registry record · Phase 1
Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
A Phase 1 study of Refractory Acute Myeloid Leukemia and Acute Leukemia of Ambiguous Lineage, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 10
- Study locations
NCT06177067 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Acute Leukemia of Ambiguous Lineage that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 24 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (49% lower). The trial reports 10 study locations across 9 states.
The verdict
NCT06177067, a Phase 1 study of Refractory Acute Myeloid Leukemia and Acute Leukemia of Ambiguous Lineage, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 10
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (49% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
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.
NCT06177067 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Texas, California, Colorado.
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.
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).
Who is sponsoring clinical trial NCT06177067?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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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Refractory Acute Myeloid Leukemia
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.