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Closed (no longer recruiting)Last updated: 7 February 2024

TRANSFORM-1: This phase III trial is testing the combination of two targeted cancer drugs (Ruxolitinib and Navitoclax) to see if it is better than using one targeted cancer drug (Ruxolitinib) to treat people with myelofibrosisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)

Clinical summary

Summary

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. Eligible participants will receive an oral navitoclax tablet with an oral ruxolitinib tablet or oral ruxolitinib tablet with an 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.

Conditions

This trial is treating patients with Myelofibrosis.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

TRANSFORM-1

More information

Trial Identifiers

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Trial sponsor

AbbVie

Scientific Title

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

Eligibility

Inclusion

  • 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 immediately preceding the date of 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.

Exclusion

  • Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.
  • Prior treatment with a B-cell lymphoma 2 homology 3 (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).

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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