ABBV-744: Tablet; Oral
Navitoclax: Tablet; Oral
Ruxolitinib: Tablet; Oral
Myelofibrosis (MF) is a bone marrow illness that affects blood-forming tissues in the body. MF disturbs the body's normal production of blood cells, causing extensive scarring in the bone marrow. This leads to severe anemia, weakness, fatigue, and an enlarged spleen. The purpose of this study is to see how safe and tolerable ABBV-744 is, when given alone, and in combination with ruxolitinib or navitoclax, for adult participants with MF.
ABBV-744 is an investigational drug being developed for the treatment of MF. The study has 4 segments - A, B, C, and D. In Segment A, the safe dosing regimen of ABBV-744 is identified and then, given alone as monotherapy. In Segment B, C, and D, combination therapies of ABBV-744 with either ruxolitinib or navitoclax are given. Adult participants with a diagnosis of MF will be enrolled. Around 130 participants will be enrolled in 60 sites worldwide.
In Segment A, participants will receive different doses and schedules of oral ABBV-744 tablet to identify safe dosing regimen. Additional participants will be enrolled at the identified monotherapy dosign regimen. In Segment B, participants will receive oral ruxolitinib and ABBV-744 will be given as "add-on" therapy. In Segment C, participants will receive ABBV-744 and oral navitoclax. In Segment D, participants will receive ABBV-744 and ruxolitinib. Participants will receive treatment until disease progression or the participants are not able to tolerate the study drugs.
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 |
|---|---|---|---|
| University of California, Davis Comprehensive Cancer Center /ID# 221790 | Sacramento | California | |
| Duplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 224623 | Lebanon | New Hampshire | |
| Roswell Park Cancer Institute /ID# 222557 | Buffalo | New York | |
| The Mount Sinai Hospital /ID# 221549 | New York | New York | |
| Weill Cornell Medical College /ID# 227069 | New York | New York | |
| Gabrail Cancer Center Research /ID# 222802 | Canton | Ohio | |
| University of Oklahoma, Stephenson Cancer Center /ID# 224095 | Oklahoma City | Oklahoma | |
| Oregon Health and Science University /ID# 221801 | Portland | Oregon | |
| Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 240004 | Dallas | Texas | |
| VA Puget Sound Health Care System /ID# 224208 | Seattle | Washington | |
| Hospital Universitario Austral /ID# 228909 | Pilar | Buenos Aires | |
| Hospital Italiano de Buenos Aires /ID# 226945 | Ciudad Autonoma Buenos Aires | Buenos Aires F.D. | |
| Townsville University Hospital /ID# 225859 | Douglas | Queensland | |
| Royal Hobart Hospital /ID# 241677 | Hobart | Tasmania | |
| Royal Perth Hospital /ID# 241678 | Perth | Western Australia | |
| Hospital das Clinicas da Universidade Federal de Goiás /ID# 226636 | Goiânia | Goiás | |
| Hospital de Clinicas de Porto Alegre /ID# 226635 | Porto Alegre | Rio Grande do Sul | |
| Duplicate_Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 226640 | São Paulo | São Paulo | |
| Instituto Nacional de Cancer (INCA) /ID# 226637 | Rio de Janeiro | Brazil | |
| Real e Benemérita Associação Portuguesa de Beneficência /ID# 226641 | São Paulo | Brazil | |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 226639 | São Paulo | Brazil | |
| SHAT Hematologic Diseases /ID# 226007 | Sofia | Bulgaria | |
| UMHAT Sveta Marina /ID# 226681 | Varna | Bulgaria | |
| Duplicate_Sociedad de Investigaciones Médicas Limitada /ID# 224175 | Temuco | Araucania | |
| Icegclinic /Id# 231086 | La Florida | Santiago Metropolitan | |
| Fundacion Arturo Lopez Perez /ID# 225037 | Providencia | Santiago Metropolitan | |
| Clinexpert Kft. Fazis I Vizsgalohely /ID# 242249 | Gyöngyös | Heves County | |
| Duplicate_Semmelweis Egyetem /ID# 224085 | Budapest | Hungary | |
| Hadassah Medical Center-Hebrew University /ID# 243852 | Jerusalem | Jerusalem | |
| The Chaim Sheba Medical Center /ID# 222151 | Ramat Gan | Tel Aviv | |
| Tel Aviv Sourasky Medical Center /ID# 223548 | Tel Aviv | Tel Aviv | |
| Duplicate_Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244397 | Milan | Milano | |
| Kyushu University Hospital /ID# 228035 | Fukuoka | Fukuoka | |
| Duplicate_Hokkaido University Hospital /ID# 228038 | Sapporo | Hokkaido | |
| Osaka Metropolitan University Hospital /ID# 225502 | Osaka | Osaka | |
| University of Yamanashi Hospital /ID# 225503 | Chuo-shi | Yamanashi | |
| Duplicate_Inje University Busan Paik Hospital /ID# 233707 | Busan | Busan Gwang Yeogsi | |
| Hospital Santa Creu i Sant Pau /ID# 238501 | Barcelona | Spain | |
| Hospital General Universitario Gregorio Maranon /ID# 233279 | Madrid | Spain | |
| Akademiska Sjukhuset /ID# 228515 | Uppsala | Uppsala County |
+ 3 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 NCT04454658 on ClinicalTrials.gov ↗ ← All trials in Italy