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NCT05849662 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia
A Phase 1 study of Neurofibromatosis 1 and Leukemia, Juvenile Myelomonocytic, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 4
- Study locations
NCT05849662: Recruiting Phase 1 study of Neurofibromatosis 1 and Leukemia, Juvenile Myelomonocytic, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT05849662 is a Phase 1 study of Neurofibromatosis 1 and Leukemia, Juvenile Myelomonocytic that is actively recruiting participants, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 58 participants, below the 1,033-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05849662, a Phase 1 study of Neurofibromatosis 1 and Leukemia, Juvenile Myelomonocytic, is actively recruiting participants, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 4
- Study locations
Study Summary
This clinical trial will test the safety and efficacy of combining trametinib and azacitidine in patients with juvenile myelomonocytic leukemia (JMML). Newly diagnosed lower-risk JMML patients will receive trametinib and azacitidine. High-risk JMML patients will receive trametinib, azacitidine, fludarabine, and cytarabine.
Primary Outcome
The incidence of dose limiting toxicities (DLTs) after the 1st course of therapy will be measured at different dose levels.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Azacitidine
- DRUG Cytarabine
- DRUG Trametinib
Study Locations (4)
California
- Children's Hospital Los Angeles - Los Angeles
- University of California San Francisco - San Francisco
District of Columbia
- Children's National Medical Center - Washington D.C.
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2024-10-11 |
| Est. Completion | 2029-12 |
| Phase | Phase 1 |
What NCT05849662 shows while recruiting
NCT05849662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,033-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine is the first listed.
NCT05849662 reports a single indexed study location in California, District of Columbia, Ohio.
Frequently Asked Questions
What is clinical trial NCT05849662 about?
NCT05849662 is a clinical study titled "A Phase I/II Study of Trametinib and Azacitidine for Patients With Newly Diagnosed Juvenile Myelomonocytic Leukemia". This clinical trial will test the safety and efficacy of combining trametinib and azacitidine in patients with juvenile myelomonocytic leukemia (JMML). Newly diagnosed lower-risk JMML patients will receive trametinib and azacitidine. High-risk JMML patients will receive trametinib, azacitidine, flud...
What is the current status of trial NCT05849662?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2024-10-11. Estimated completion is 2029-12.
What conditions does trial NCT05849662 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Leukemia, Juvenile Myelomonocytic, JMML, JCML, CBL Syndrome.
What interventions are being tested in trial NCT05849662?
The interventions under investigation include: Fludarabine (DRUG), Azacitidine (DRUG), Cytarabine (DRUG), Trametinib (DRUG).
Who is sponsoring clinical trial NCT05849662?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05849662 being conducted?
This trial has 4 study locations across California, District of Columbia, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05849662's enrollment target sits among peer trials
58 15th of 24 higher than 9 of 24 other Neurofibromatosis 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis 1 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.
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