A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis (REFINE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03222609|
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : March 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Myelofibrosis (MF)||Drug: Ruxolitinib Drug: Navitoclax||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis (REFINE)|
|Actual Study Start Date :||October 31, 2017|
|Estimated Primary Completion Date :||February 26, 2022|
|Estimated Study Completion Date :||February 2, 2029|
Experimental: Navitoclax + ruxolitinib
Participants will be administered navitoclax once daily (QD) at various doses and a dose greater than or equal to 10 mg of ruxolitinib twice daily (BID).
Other Name: Jakafi
Other Name: ABT-263
Participants will be administered various doses of navitoclax once daily (QD)
Other Name: ABT-263
- Percentage of Participants who achieve Spleen Volume Reduction of greater than or equal to 35% (SVR35) from baseline [ Time Frame: From Baseline (Week 0) through Week 24 ]Reduction in spleen volume is measured by magnetic resonance imaging (MRI).
- Percentage of participants achieving 50% Reduction in Total System Score (TSS) [ Time Frame: From Baseline (Week 0) through Week 24 ]TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0.
- Anemia Response [ Time Frame: Every 12 weeks up to approximately 96 weeks ]The anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.
- Change in Grade of Bone Marrow Fibrosis [ Time Frame: Through Week 96 ]Bone marrow grading is assessed according to the European Consensus Grading System.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222609
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|Study Director:||AbbVie Inc.||AbbVie|