Study of Navtemadlin Add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
- Conditions
- MyelofibrosisPost-ET MyelofibrosisPrimary MyelofibrosisPost-PV MFMF
- Interventions
- Registration Number
- NCT06479135
- Lead Sponsor
- Kartos Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Navtemadlin Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Arm 2 Navtemadlin placebo Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Arm 1 Ruxolitinib Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Arm 2 Ruxolitinib Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.
- Primary Outcome Measures
Name Time Method To compare total symptom score reduction (TSS50) between Arm 1 and Arm 2 24 weeks The proportion of subjects in each arm with a TSS50 by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 24 weeks after start of the randomized period
To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2 24 weeks The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period
- Secondary Outcome Measures
Name Time Method To compare time to progression between Arm 1 and Arm 2 Up to 8 years Time to progression or death from any cause in subjects randomized to each arm
To compare overall survival (OS) between Arm 1 and Arm 2 Up to 8 years Time to death from any cause in subjects randomized to each arm
Related Research Topics
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Trial Locations
- Locations (79)
St George Hospital
🇦🇺Kogarah, Australia
Rocky Mountain Cancer Centers - Aurora
🇺🇸Aurora, Colorado, United States
Medical Oncology Hematology Consultants, PA
🇺🇸Newark, Delaware, United States
Mission Cancer + Blood
🇺🇸Des Moines, Iowa, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
The Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Nebraska Hematology - Oncology, P.C.
🇺🇸Lincoln, Nebraska, United States
Montefiore Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Brookdale University Hospital and Medical Center
🇺🇸Brooklyn, New York, United States
Cayuga Cancer Center
🇺🇸Ithaca, New York, United States
Atrium Health Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Independence Family Health Center - Cleveland Clinic
🇺🇸Independence, Ohio, United States
Hillcrest Hospital - Cleveland Clinic
🇺🇸Mayfield Heights, Ohio, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
U.T. MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Virginia Oncology Associates - Virginia Beach
🇺🇸Virginia Beach, Virginia, United States
Northwest Medical Specialties, PLLC - Tacoma
🇺🇸Tacoma, Washington, United States
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Monash Medical Center Clayton
🇦🇺Clayton, Australia
Townsville University Hospital
🇦🇺Douglas, Australia
Gosford Hospital
🇦🇺Gosford, Australia
The Royal Melbourne Hospital - Peter MacCallum Cancer Center
🇦🇺Melbourne, Australia
The Alfred Hospital
🇦🇺Melbourne, Australia
Calvary Mater Newcastle Hospital
🇦🇺Waratah, Australia
University Hospitals Leuven, Campus Gasthuisberg
🇧🇪Leuven, Belgium
General Hospital Delta
🇧🇪Roeselare, Belgium
UCL Mont-Godinne University Hospitals
🇧🇪Yvoir, Belgium
Clinical Hospital Centre Rijeka
🇭🇷Rijeka, Croatia
General Hospital of Sibenik-Knin County
🇭🇷Sibenik, Croatia
University Hospital of Split
🇭🇷Split, Croatia
Clinical Hospital Dubrava
🇭🇷Zagreb, Croatia
Clinical Hospital Merkur
🇭🇷Zagreb, Croatia
Solmed Clinic
🇭🇷Zagreb, Croatia
University Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
JSC Vian
🇬🇪Kutaisi, Georgia
JSC German Hospital
🇬🇪Tbilisi, Georgia
LEPL The First University Clinic of Tbilisi State Medical University
🇬🇪Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
🇬🇪Tbilisi, Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
🇬🇪Tbilisi, Georgia
Caucasus Medical Centre LLC
🇬🇪Tbilisi, Georgia
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Keimyung University - Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
University Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Clinical Hospital Center Bezanijska Kosa
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
Caceres Hospital Complex - San Pedro de Alcantara General Hospital
🇪🇸Cáceres, Spain
Gran Canaria Dr Negrin University Hospital
🇪🇸Las Palmas De Gran Canaria, Spain
University Hospital 12 de Octubre
🇪🇸Madrid, Spain
University Hospital Ramon y Cajal
🇪🇸Madrid, Spain
University Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
University and Polytechnic Hospital La Fe
🇪🇸Valencia, Spain
Quironsalud Zaragoza Hospital
🇪🇸Zaragoza, Spain
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, United Kingdom
The Clatterbridge Cancer Center NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom
Genesis Care, Oxford
🇬🇧Oxford, United Kingdom
Genesis Care, Windsor
🇬🇧Windsor, United Kingdom