Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Myelofibrosis (MF)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Laboratory values indicative of adequate bone marrow, renal, and hepatic function meeting protocol criteria.
- 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.
- 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).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of \<= 2.
- 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).
- 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:
- Segment A:
- 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.
- Segment B:
- Currently receiving ruxolitinib AND
- 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
- At least one of the following criteria (a, b, or c):
- \>= 24 weeks duration of current ruxolitinib course, with evidence of disease that is resistant, refractory, or has lost response to ruxolitinib therapy;
- \< 24 weeks duration of current ruxolitinib course with documented resistance, refractories, or loss of response, as defined by any of the following:
- Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM), in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.
- \>=100% increase in the palpable distance below the LCM, in participants with measurable spleen distance 5 - 10 cm prior to the initiation of ruxolitinib.
- \>=50% increase in the palpable distance below the LCM, in participants with measurable spleen \> 10 cm prior to the initiation of ruxolitinib.
- A spleen volume increase \>= 25% (as assessed by MRI or CT) in participants with a spleen volume assessment available prior to the initiation of ruxolitinib.
- Prior treatment with ruxolitinib for \>= 28 days complicated by any of the following:
- Development of red blood cell transfusion requirement (at least 2 units/month for 2 months).
- Grade \>= 3 adverse events of neutropenia and/or anemia while on ruxolitinib treatment, with improvement or resolution upon dose reduction.
- Segment C:
- Prior exposure to one or more 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.
Exclusion
- Segment-Specific Prior Therapy Criteria:
- Segment A:
- Prior exposure to one or more Bromodomain and Extra-Terminal (BET) inhibitors.
- Segment B:
- Prior exposure to one or more BET inhibitors.
- Segment C:
- Prior exposure to one or more BET inhibitors and/or any B-Cell Lymphoma 2 (BCL)-2 and/or BCL- XL inhibitor, including navitoclax.
- Segment D:
- Prior exposure to JAKi and/or any BET inhibitor.
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04454658
Start Date
November 11 2020
End Date
January 1 2027
Last Update
July 16 2025
Active Locations (43)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, Davis Comprehensive Cancer Center /ID# 221790
Sacramento, California, United States, 95817
2
Duplicate_Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 224623
Lebanon, New Hampshire, United States, 03756
3
Roswell Park Cancer Institute /ID# 222557
Buffalo, New York, United States, 14263
4
The Mount Sinai Hospital /ID# 221549
New York, New York, United States, 10029