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NCT03190915 · ClinicalTrials.gov registry record · Phase 2
Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
A Phase 2 study of Neurofibromatosis Type 1 and Juvenile Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 20
- Study locations
NCT03190915: Active Phase 2 study of Neurofibromatosis Type 1 and Juvenile Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).
NCT03190915 is a Phase 2 study of Neurofibromatosis Type 1 and Juvenile Myelomonocytic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 160-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03190915, a Phase 2 study of Neurofibromatosis Type 1 and Juvenile Myelomonocytic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well trametinib works in treating patients with juvenile myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed accounting for the two-stage design. A responder is defined as a patient who achieves a best response of PR or CR on the study prior to having an overall response of PD; all others will be considered non-responders. The definitions of response are based on a publication (PMID: 25552679) entitled "Criteria for evaluating response and outcome in clinical trials fo
Conditions Studied
Interventions
- DRUG Trametinib
- PROCEDURE Bone Marrow Aspiration and Biopsy
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- UCSF Medical Center-Mission Bay - San Francisco
Florida
- Nemours Children's Clinic-Jacksonville - Jacksonville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Nicklaus Children's Hospital - Miami
- Arnold Palmer Hospital for Children - Orlando
- Nemours Children's Hospital - Orlando
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
- Children's National Medical Center - Washington D.C.
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-09-09 |
| Est. Completion | 2026-10-03 |
| Phase | Phase 2 |
What the registry record for NCT03190915 still lists
NCT03190915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 160-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Neurofibromatosis Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Trametinib is the first listed.
NCT03190915 names 20 study sites across 9 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT03190915 about?
NCT03190915 is a clinical study titled "Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia". This phase II trial studies how well trametinib works in treating patients with juvenile myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT03190915?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2018-09-09. Estimated completion is 2026-10-03.
What conditions does trial NCT03190915 study?
This clinical trial studies the following conditions: Neurofibromatosis Type 1, Juvenile Myelomonocytic Leukemia.
What interventions are being tested in trial NCT03190915?
The interventions under investigation include: Trametinib (DRUG), Bone Marrow Aspiration and Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03190915?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03190915 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neurofibromatosis Type 1
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 NCT03190915's enrollment target sits among peer trials
10 17th of 17 higher than 1 of 17 other Neurofibromatosis Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis Type 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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