Adding Navtemadlin to Ruxolitinib for Patients with Myelofibrosis
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
IRAS ID
1008144
Contact name
John Mei
Contact email
Sponsor organisation
Kartos Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
Myelofibrosis (MF) is a cancer of the blood and bone marrow that causes the spleen to swell, patient well-being to decrease, and blood cell function to drop. MF can be treated with medicines such as ruxolitinib to decrease spleen size and improve patient well-being. However, ruxulotinib does not fully help every patient. New medicines that can be added to ruxulotinib are needed to improve MF treatment. Inside the human body, diseased cells usually self-destruct. This is part of the body’s natural protection against cancer. This protection may be turned off or reduced by cancer cells, which limits the body’s ability to fight further cancer growth. Navtemadlin is a molecule that may boost the self-destruction of diseased cells.
In this study, the addition of navtemadlin to ruxolitinib is being tested in patients with MF to find out if it further improves patients’ symptoms and shrinks spleen size more than ruxolitinib alone.
In Part 1 of the study, patients with MF will receive RUX only. In Part 2, patients that have only a small benefit from RUX will receive NVTM or placebo as add-on therapy to ongoing RUX in a randomized, double-blind way. A placebo does not have any medicine in it, but it looks just like navtemadlin medicine. Randomized means that patients will be assigned to each group by chance, like a flip of a coin. Double-blind means that neither the patients nor the doctor will know whether they are receiving navtemadlin or placebo. Patients may participate in the study until cancer growth is found, they have any unacceptable medical problems, have side effects from treatment, or they decide to leave the study.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0481
Date of REC Opinion
23 Jul 2024
REC opinion
Further Information Favourable Opinion