[M16-191] A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Navitoclax inCombination with Ruxolitinib Versus Ruxolitinib in Subjects with Myelofibrosis (TRANSFORM-1)

Okubo Sumiko0 个研究点目标入组 23 人开始时间: 2021年7月30日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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 prior to 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.
•- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

•- Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.
•- Prior treatment with a 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).

发起方

Okubo Sumiko