Status:
COMPLETED
Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis
Lead Sponsor:
AbbVie
Conditions:
Myelofibrosis (MF)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause...
Eligibility Criteria
Inclusion
- Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera \[PPV\] - MF or Post Essential Thrombocytopenia \[PET\] - MF) .
- Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days immediately preceding the date of randomization.
- \-- Must have at least 2 symptoms with a score \>=3 or a total score of \>=12, as measured by the MFSAF v4.0.
- Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
- Has splenomegaly defined as spleen palpation measurement \>= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
- Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant and other criteria per National Comprehensive Cancer Network guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion
- Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.
- Prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant.
- Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 milligram daily) and low molecular weight heparin (LMWH).
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2025
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT04472598
Start Date
September 29 2020
End Date
January 29 2025
Last Update
February 21 2025
Active Locations (194)
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1
Highlands Oncology Group, PA /ID# 221824
Springdale, Arkansas, United States, 72762
2
Providence - St. Jude Medical Center /ID# 241646
Fullerton, California, United States, 92835
3
Moores Cancer Center at UC San Diego /ID# 218012
La Jolla, California, United States, 92093
4
Rocky Mountain Cancer Centers - Littleton /ID# 222562
Littleton, Colorado, United States, 80120