TRANSFORM-2
About the trial
A Randomized, Open-Label, Phase 3 Study Evaluating safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with Myelofibrosis.
Planned enrolment is 330 participants in 206 study locations.
Lay summary: The purpose of this study is to evaluate the safety, tolerability, and change in spleen volume when navitoclax is administered in combination with ruxolitinib compared to the 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 two arms - A and B. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive 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 in approximately 23 countries worldwide.
How DCR - CIU supports the trial
DCR - CIU is involved in the maintenance of the Investigator Site File, performed patient pre-screening and supported the study PI with coordinative and organizational aspects of the trial.
Principal Investigator
Prof. Dr. med. Alicia Rovó, Universitätsklinik für Hämatologie und Hämatologisches Zentrallabor
Sponsor
AbbVie