臨床研究等提出・公開システム

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

[M16-191] Myelofibrosis: Phase 3 Study of Navitoclax Plus Ruxolitinib Versus Ruxolitinib

Tsutsui Atsuko

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo, Japan

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie. G.K.

3-1-21 Shibaura, Minato-ku, Tokyo, Japan

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Not Recruiting

July. 01, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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 and other criteria per National Comprehensive Cancer Network guidelines.
- 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).

Both

Myelofibrosis

Experimental: Arm A: Navitoclax + Ruxolitinib
- Participants will receive Navitoclax in combination with Ruxolitinib
Active Comparator: Arm B: Placebo for Navitoclax + Ruxolitinib
- Participants will receive placebo for Navitoclax and Ruxolitinib

Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)

+81-562-93-2873

Oct. 19, 2020

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing.html

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