BridgeMD
New treatment option for Myelofibrosis
Official title Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
ClinicalTrials.gov ID: NCT06479135
What this study is testing
What is Navtemadlin?
Navtemadlin is an investigational medicine, being studied as a potential treatment for myelofibrosis.
Also referred to as KRT-232.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for Ruxolitinib Alone Period:
- Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria
- High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- JAK-inhibitor treatment naive
You likely can't join if
- for Ruxolitinib Alone Period:
- Prior Splenectomy
- Splenic irradiation within 3 months prior to the first dose
- Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy
- Eligible for Bone Marrow Transplant
- Peripheral blood or bone marrow blast count ≥ 10 percent Inclusion Criteria for assigned by chance Period:
See the full eligibility criteria
- for Ruxolitinib Alone Period:
- Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria
- High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- JAK-inhibitor treatment naive
- for Ruxolitinib Alone Period:
- Prior Splenectomy
- Splenic irradiation within 3 months prior to the first dose
- Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy
- Eligible for Bone Marrow Transplant
- Peripheral blood or bone marrow blast count ≥ 10 percent Inclusion Criteria for assigned by chance Period:
- PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing
- ECOG performance status of 0 to 2
- Treatment with a stable dose of ruxolitinib
- Suboptimal response to run-in ruxolitinib treatment Exclusion Criteria for assigned by chance Period:
- Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10\^9/L
- Peripheral blood or bone marrow blast count ≥ 10 percent
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Newark, Delaware, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Des Moines, Iowa, United States
- Westwood, Kansas, United States
- Louisville, Kentucky, United States
- Baton Rouge, Louisiana, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
+ 165 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Phoenix, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; San Diego, California, United States and 179 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.