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Clinical Trials List

Protocol NumberM16-191
NCT Number(ClinicalTrials.gov Identfier)NCT04472598
Completed

2020-08-01 - 2028-09-30

Phase III

Not yet recruiting4

Recruiting2

ICD-10D75.81

Myelofibrosis

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Lee-Yung Shin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Liang-Tsai Hsiao Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 曹朝榮 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator HSIN-AN HOU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 馬銘君 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Myelofibrosis (MF)

Objectives

Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis.Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 130 sites worldwide.Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue till the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug.There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, Magnetic Resonance Imaging (MRI), bone marrow tests, checking for side effects, and completing questionnaires.

Test Drug

Navitoclax

Active Ingredient

Navitoclax
Navitoclax

Dosage Form

tablet

Dosage

25mg/tab
100mg/tab

Endpoints

Primary Outcome Measures :

Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24) [ Time Frame: At Week 24 ]
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.

Inclution Criteria

Inclusion Criteria:

Documented diagnosis of Primary MyeloFibrosis (MF) or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) as defined by World Health Organization (WHO) classification.
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.

Exclusion Criteria

Exclusion Criteria:

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.
Receiving medication that interferes with coagulation or platelet function except for low dose aspirin (up to 100 milligram daily) and low molecular weight heparin (LMWH) within 3 days prior to the first dose of study drug or during the study treatment period.

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    230 participants

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