Safety and Tolerability Study of Oral ABBV-744 Tablet Alone or in Combination With Oral Ruxolitinib Tablet or Oral Navitoclax Tablet in Adult Participants With Myelofibrosis (NCT04454658)

🧪 Interventions in This Study

• ABBV-744 (DRUG)
• Navitoclax (DRUG)
• Ruxolitinib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Laboratory values indicative of adequate bone marrow, renal, and hepatic function meeting protocol criteria.
2. Completion of the Myelofibrosis System Assessment Form (MFSAF) on at least 4 out of the 7 days prior to Day 1 with at least 2 symptoms with a score \>=3 or a total score of \>=10.
3. Documented diagnosis of intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF) or post-essential thrombocytopenia MF (PET-MF) as defined by the World Health Organization (WHO).
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of \<= 2.
5. Intermediate - 2, or High-Risk disease as defined by the Dynamic International Prognostic Scoring System (For Segment A only, Intermediate - 1 with palpable splenomegaly \>=5 centimeters \[cm\] below costal margin are also eligible).
6. Splenomegaly defined as spleen palpation measurement \>= 5 cm below costal margin or spleen volume \>= 450 cubic cms as assessed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan (for Segments A and C, baseline spleen assessment must be obtained \> 7 days after discontinuation of most recent Myelofibrosis (MF) therapy. If possible, this assessment should occur within 10 days of Cycle 1 Day 1). Segment-Specific Prior Therapy Criteria:
7. Segment A:
8. Prior exposure to one or more Janus Kinase inhibitors (JAKi),\[the most recent of which was discontinued \> 14 days prior to Cycle 1 Day 1\] and are intolerant, resistant, refractory or lost response to the JAKi.
9. Segment B:
10. Currently receiving ruxolitinib AND
11. Willingness to reduce ruxolitinib dose (if on a higher dose); and on a stable dose for 14 days or longer prior to Cycle 1 Day 1; AND
12. At least one of the following criteria (a, b, or c):

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (43 Sites)

Showing the first 25 of 43 sites.

• 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,
• Real e Benemérita Associação Portuguesa de Beneficência /ID# 226641 — São Paulo,
• Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 226639 — São Paulo,
• SHAT Hematologic Diseases /ID# 226007 — Sofia,
• UMHAT Sveta Marina /ID# 226681 — Varna,
• Duplicate_Sociedad de Investigaciones Médicas Limitada /ID# 224175 — Temuco, Araucania
• Icegclinic /Id# 231086 — La Florida, Santiago Metropolitan

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: In Segment A, participants will receive different doses and schedules of oral ABBV-744 tablet to identify safe dosing regimen.

More studies in Myelofibrosis (MF)

• 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 — Chandler, Arizona
• Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML) — Houston, Texas

Explore by condition: All Myelofibrosis (MF) clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.