A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Navitoclax in Combination with Ruxolitinib Versus Ruxolitinib in Subjects with Myelofibrosis - TRANSFORM-1

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 230 人开始时间: 2021年6月1日最近更新: 2022年2月7日

适应症

试验速览

暂无简介。

•Subject = 18 years of age.
•Subject with a documented diagnosis of primary myelofibrosis (MF) or secondary MF (post polycythemia vera [PPV] -MF or post essential thrombocythemia [PET] – MF) as defined by the World Health Organization classification.
•Subject must be able to complete the Myelofibrosis Symptom Assessment Form (MFSAF) on at least 4 out of 7 days prior to randomisation.
•- Subject classified as intermediate-2 or high-risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
•Subject has splenomegaly defined as spleen palpation measurement = 5 cm below costal margin or spleen volume = 450 cm^3 as assessed centrally by MRI or CT scan.
•Subject has at least 2 symptoms measurable (score = 3) or a total score of = 12, as measured by the MFSAF v4.0.
•Subject with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 92
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 138

•Subject must not have received prior treatment with a JAK-2 inhibitor.
•Subject must not have received prior treatment with a BH3-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor.
•Subject must not be eligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant.
•Subject must not receive 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.

发起方