M20-178 Navitoclax for Relapsed/Refractory Myelofibrosis
Research type
Research Study
Full title
A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination with Ruxolitinib Versus Best Available Therapy in Subjects with Relapsed/Refractory Myelofibrosis
IRAS ID
284888
Contact name
Claire Harrison
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2020-000557-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 9 months, 29 days
Research 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 leads to severe anemia, weakness, fatigue, and an enlarged spleen. The purpose of this study is to assess safety, tolerability, and change in spleen volume when navitoclax is given in combination with ruxolitinib, as compared to best available therapy, for adult participants with MF.
Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. The study has 2 arms - A and B. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. Adult participants with a diagnosis of relapsed/refractory (R/R) MF will be enrolled. Approximately 330 participants will be enrolled in the study at approximately 23 countries worldwide. In Arm A, participants will receive oral navitoclax tablet once daily with oral ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT as identified by the investigator. Treatment will continue until clinical benefit is not seen, participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 18 months.
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.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0250
Date of REC Opinion
20 Nov 2020
REC opinion
Further Information Favourable Opinion