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AbbVie Myelofibrosis Research Studies

In the double-blind placebo-controlled Phase 3 TRANSFORM-1 study, the investigational medication (navitoclax) in combination with ruxolitinib will be compared to ruxolitinib with matching placebo, to evaluate its effect on splenomegaly, bone marrow fibrosis, anemia responses and quality of life.

Navitoclax, an investigational agent, is under clinical development and is not approved by regulatory health authorities. Safety and efficacy are under evaluation.

ClinicalTrials.gov Identifier: NCT04472598
EudraCT Number: 2020-000097-15

Enrollment has now closed for this trial .

ENVELOP is a multi-part clinical research study for adults with MPN and Myelofibrosis (MF), enrolling in various global regions. This information will be focusing on Part 5 of the study.

Part 5 is for patients with MF who are requiring treatment and either have no prior treatment with a JAK2 inhibitor or have received ruxolitinib (prior or current) to evaluate the impact of navitoclax on the pharmacokinetics (PK) of ruxolitinib. After completing PK assessments, patients may continue to receive navitoclax and ruxolitinib in the study as long as they are receiving benefit and tolerating the combination.

Eligibility Criteria (Part 5)

  • Are 18 years of age or older
  • Have a documented diagnosis of primary MF as defined by the WHO classification, post-PV MF, or post-ET MF.
  • Classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System (DIPSS).
  • Requiring treatment for MF and must either have no prior treatment with a JAK2 inhibitor or have received treatment with ruxolitinib (current or prior treatment with ruxolitinib as noted in the protocol)
  • Have an ECOG performance status <=2.
  • Have adequate bone marrow, kidney, liver and hematology blood values as detailed in the protocol
Navitoclax, an investigational agent, is under clinical development and is not approved by regulatory health authorities. Safety and efficacy are under evaluation.

ClinicalTrials.gov Identifier: NCT04041050
EudraCT Number: 2020-000557-27

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