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Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
Condition: Myelofibrosis (MF) · Sponsor: AbbVie
About this study
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…
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (229)
| Ironwood Cancer & Res Ctr /ID# 222162 | Chandler, Arizona, United States | — |
| Highlands Oncology Group, PA /ID# 221826 | Springdale, Arkansas, United States | — |
| City of Hope /ID# 218996 | Duarte, California, United States | — |
| Providence - St. Jude Medical Center /ID# 271382 | Fullerton, California, United States | — |
| Moores Cancer Center /ID# 271596 | La Jolla, California, United States | — |
| Moores Cancer Center at UC San Diego /ID# 219009 | La Jolla, California, United States | — |
| Long Beach Memorial Medical Ct /ID# 224542 | Long Beach, California, United States | — |
| Icri /Id# 221967 | Whittier, California, United States | — |
| St. Mary's Hospital Regional Cancer Center /ID# 224229 | Grand Junction, Colorado, United States | — |
| Augusta University Georgia Cancer Center /ID# 219051 | Augusta, Georgia, United States | — |
| Columbus Regional Research Institute /ID# 224410 | Columbus, Georgia, United States | — |
| University of Chicago Medical Center /ID# 271373 | Chicago, Illinois, United States | — |
+ 217 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04468984