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NCT06479135 · ClinicalTrials.gov registry record · Phase 3
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
A Phase 3 study of Myelofibrosis and Primary Myelofibrosis, sponsored by Kartos Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT06479135: Recruiting Phase 3 study of Myelofibrosis and Primary Myelofibrosis, sponsored by Kartos Therapeutics.
NCT06479135 is a Phase 3 study of Myelofibrosis and Primary Myelofibrosis that is actively recruiting participants, run by Kartos Therapeutics. The registered enrollment target is 600 participants, above the 186-participant average among 61 other Myelofibrosis trials with a reported enrollment target (223% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06479135, a Phase 3 study of Myelofibrosis and Primary Myelofibrosis, is actively recruiting participants, sponsored by Kartos Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.
Primary Outcome
The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Navtemadlin
- DRUG Navtemadlin placebo
Study Locations (20)
California
- UC San Diego Moores Cancer Center - La Jolla
- UCLA Hematology/Oncology Clinic - Los Angeles - Los Angeles
- Scripps Health, Prebys Cancer Center - San Diego
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Florida
- Mayo Clinic - Jacksonville - Jacksonville
- University of Miami - Miami
- AdventHealth Cancer Institute - Orlando
- Moffitt Cancer Center - Tampa
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic - Phoenix - Phoenix
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore
- The Center for Cancer and Blood Disorders - Bethesda
Alabama
- UAB Hospital - Birmingham
Colorado
- Rocky Mountain Cancer Centers - Aurora - Aurora
Delaware
- Medical Oncology Hematology Consultants, PA - Newark
District of Columbia
- MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
What NCT06479135 shows while recruiting
NCT06479135 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 186-participant average among 61 other Myelofibrosis trials with a reported enrollment target (223% higher).
The record links to 5 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 3 interventions - of which Ruxolitinib is the first listed.
NCT06479135 names 20 study sites across 12 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06479135 about?
NCT06479135 is a clinical study titled "Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib". This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in t...
What is the current status of trial NCT06479135?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2024-06-03. Estimated completion is 2028-12-31.
What conditions does trial NCT06479135 study?
This clinical trial studies the following conditions: Myelofibrosis, Primary Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis, MF.
What interventions are being tested in trial NCT06479135?
The interventions under investigation include: Ruxolitinib (DRUG), Navtemadlin (DRUG), Navtemadlin placebo (DRUG).
Who is sponsoring clinical trial NCT06479135?
This trial is sponsored by Kartos Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06479135 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelofibrosis
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 NCT06479135's enrollment target sits among peer trials
600 3rd of 61 higher than 59 of 61 other Myelofibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelofibrosis 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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