Study of Navtemadlin add-on to Ruxolitinib With Myelofibrosis

Overview

About this study

The purpsoe of this study is to evaluate 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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

Exclusion Criteria 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 Randomized 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 Randomized 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/08/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla. Mayo Clinic principal investigator Candido Rivera Linares, M.D.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Jeanne Palmer, M.D.	Open for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Candido Rivera Linares, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials