Navitoclax: Tablet; Oral
Ruxolitinib: Tablet; Oral
Best Available Therapy (BAT): Tablet/Capsule; Oral or Solution for Subcutaneous Injection
Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF.
Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. In Arm C, participants will receive navitoclax. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 322 sites across the world.
In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. In Arm C, participants will receive navitoclax tablet by mouth once daily. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.
| Facility | City | Region | Status |
|---|---|---|---|
| Ironwood Cancer & Res Ctr /ID# 222162 | Chandler | Arizona | |
| Highlands Oncology Group, PA /ID# 221826 | Springdale | Arkansas | |
| City of Hope /ID# 218996 | Duarte | California | |
| Providence - St. Jude Medical Center /ID# 271382 | Fullerton | California | |
| Moores Cancer Center /ID# 271596 | La Jolla | California | |
| Moores Cancer Center at UC San Diego /ID# 219009 | La Jolla | California | |
| Long Beach Memorial Medical Ct /ID# 224542 | Long Beach | California | |
| Icri /Id# 221967 | Whittier | California | |
| St. Mary's Hospital Regional Cancer Center /ID# 224229 | Grand Junction | Colorado | |
| Augusta University Georgia Cancer Center /ID# 219051 | Augusta | Georgia | |
| Columbus Regional Research Institute /ID# 224410 | Columbus | Georgia | |
| University of Chicago Medical Center /ID# 271373 | Chicago | Illinois | |
| Northwest Oncology & Hematology - Elk Grove Village /ID# 222818 | Elk Grove Village | Illinois | |
| Loyola University Medical Ctr /ID# 219048 | Maywood | Illinois | |
| Indiana Blood & Marrow Transpl /ID# 221587 | Indianapolis | Indiana | |
| Tulane Medical Center - New Orleans /ID# 222940 | New Orleans | Louisiana | |
| Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 222777 | New Orleans | Louisiana | |
| American Oncology Partners of Maryland /ID# 222836 | Bethesda | Maryland | |
| Dana-Farber Cancer Institute /ID# 218998 | Boston | Massachusetts | |
| University of Michigan /ID# 218463 | Ann Arbor | Michigan | |
| Henry Ford Hospital /ID# 221190 | Detroit | Michigan | |
| William Beaumont Hospital /ID# 222705 | Royal Oak | Michigan | |
| Saint Louis University Cancer Center /ID# 222287 | St Louis | Missouri | |
| Summit Medical Group-Florham Park /ID# 222620 | Florham Park | New Jersey | |
| Hackensack Univ Med Ctr /ID# 219047 | Hackensack | New Jersey | |
| The Cancer Institute at St. Francis Hospital /ID# 231782 | Greenvale | New York | |
| Manhattan Hematology Oncology MHO Associates /ID# 223193 | New York | New York | |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081 | New York | New York | |
| Atrium Health Wake Forest Baptist Medical Center /ID# 222899 | Winston-Salem | North Carolina | |
| MetroHealth Medical Center /ID# 222650 | Cleveland | Ohio | |
| Pennsylvania Cancer Specialists & Research Institute /ID# 271376 | Gettysburg | Pennsylvania | |
| Hospital of the University of Pennsylvania /ID# 219001 | Philadelphia | Pennsylvania | |
| Fox Chase Cancer Center /ID# 223955 | Philadelphia | Pennsylvania | |
| Texas Oncology - Abilene - Antilley Road /ID# 271379 | Abilene | Texas | |
| Duplicate_Houston Methodist Hospital /ID# 223103 | Houston | Texas | |
| University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942 | San Antonio | Texas | |
| Utah Cancer Specialists Salt Lake Clinic /ID# 221962 | Salt Lake City | Utah | |
| Virginia Cancer Specialists - Fairfax /ID# 223016 | Fairfax | Virginia | |
| Providence Everett /ID# 223130 | Everett | Washington | |
| Yakima Valley Memorial Hosp /ID# 224368 | Yakima | Washington |
+ 189 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04468984 on ClinicalTrials.gov ↗ ← All trials in the UK