At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Navtemadlin (drug), Navtemadlin placebo (drug), Ruxolitinib (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Navtemadlin — drug: Navtemadlin is an investigational MDM2 inhibitor · Navtemadlin placebo — drug: Navtemadlin placebo · Ruxolitinib — drug: Ruxolitinib is a janus kinase 1/2 inhibitor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at people with myelofibrosis, a rare bone marrow cancer, including types that develop from other blood conditions (post-PV MF and post-ET MF). It tests whether adding a new medicine called navtemadlin to an existing medicine called ruxolitinib helps people whose response to ruxolitinib alone has not been good enough. The study is run by Kartos Therapeutics, Inc.
Who can take part
- A confirmed diagnosis of myelofibrosis (primary myelofibrosis, post-PV MF, or post-ET MF), judged by a doctor using World Health Organization (WHO) criteria
- A risk score of high, Intermediate-1, or Intermediate-2 on a system called the International Prognosis System Score (IPSS)
- Being well enough for daily activity (performance status of 0 to 2 on a scale called ECOG)
- Not having had treatment with a JAK inhibitor before (ruxolitinib is a JAK inhibitor)
- For the second part of the study: myelofibrosis that tests normal for a gene called TP53 (TP53WT), being on a stable dose of ruxolitinib, and having had a less-than-good response to ruxolitinib during the first part of the study
Who may not be able to
- Having had your spleen removed in the past
- Having had radiotherapy to the spleen in the 3 months before the first dose
- Past treatment with certain other medicines (BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors) or therapy aimed at a protein called p53
- Being able to have a bone marrow transplant
- Having 10 percent or more of early white blood cells (called blasts) in the blood or bone marrow
- For the second part: a white blood cell count that doubles (or more) during ruxolitinib treatment and goes above a set high level
What taking part involves
- • First, taking ruxolitinib on its own (you must not have had a JAK inhibitor before)
- • If your response to ruxolitinib alone is not good enough, you may move into the second part of the study, where you are given either navtemadlin added to ruxolitinib or continued treatment — how this is decided is not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how long the study lasts, how often you would need to attend visits, and what tests or checks would be involved.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 600
- Started
- 2024-06-03
- Last checked
- 2024-10
Plain English Summary
What is this study?
- • Testing a new treatment for myelofibrosis
- • Phase3 - 600 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with myelofibrosis
Where?
- • Birmingham - Birmingham Heartlands Hospital
- • Boston - Lincoln County Hospital
- • Boston - Pilgrim Hospital
- • Cambridge - Addenbrooke's Hospital
- • +10 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
What the study is looking for
- ✓Inclusion 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...
- ✓High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
- ✓activity scale (ECOG) performance status of 0 to 2
- ✓JAK-inhibitor treatment naive
See the full criteria
Where Is This Study? (14 UK sites)
Birmingham Heartlands Hospital
Birmingham B9 5SS, United Kingdom
Lincoln County Hospital
Boston Lincoln County Hospital, United Kingdom
Pilgrim Hospital
Boston PE21 9QS, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
Western General Hospital, Lothian Health Board
Edinburgh EH4 2XU, United Kingdom
Gloucestershire Royal Hospital
Gloucester GL1 3NN, United Kingdom
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467Harrogate District Hospital
Harrogate HG2 7SX, United Kingdom
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351The Clatterbridge Cancer Center NHS Foundation Trust
Liverpool L7 8YA, United Kingdom
University College Hospital
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Guy's Hospital
London SE1 9RT, United Kingdom
Genesis Care, Oxford
Oxford OX4 6LB, United Kingdom
Genesis Care, Windsor
Windsor SL4 3HD, United Kingdom
How to Get in Touch
John Mei
Sponsor contactCONTACT