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Myelofibrosis Research Study by AbbVie

In the randomized open-label Phase 3 TRANSFORM-2 study, the investigational medication (navitoclax) in combination with ruxolitinib is compared to best available therapy to evaluate its effect on splenomegaly, bone marrow fibrosis, anemia responses and quality of life in relapsed/refractory myelofibrosis patients.

Eligibility Criteria

  • Are 18 years of age or older
  • Have been diagnosed with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis, characterized by bone marrow fibrosis grades 2 or 3.
  • Currently have Intermediate-2 or High-Risk myelofibrosis
  • Have received prior treatment with a JAK-2 inhibitor therapy, ruxolitinib
        • Treatment with ruxolitinib for ≥ 24 weeks that was stopped due to lack of spleen response (refractory), or loss of spleen response or symptom control after a previous response (relapsed), or was continued despite relapsed/refractory status.
        • Treatment with ruxolitinib for < 24 weeks with documented disease progression
        • Prior or current treatment with ruxolitinib of at least 10 mg BID for ≥ 28 days with intolerance defined as new RBC transfusion requirement (at least 2 units/month for 2 months) while receiving a total daily ruxolitinib dose of ≥ 30 mg but unable to reduce dose further due to lack of efficacy.
Note: Subject must not require a ruxolitinib dose less than 10 mg BID (20 mg daily) due to prior history of ruxolitinibrelated ≥ Grade 3 toxicity
  • Have splenomegaly of at least 5 cm or spleen volume  ≥ 450 cm3
  • Have at least 2 symptoms each with an average score ≥ 3 or an average total score of ≥ 12, as measured by the MFSAF v4.0 prior to randomization. Subject must complete the MFSAF v4.0 on at least 4 out of the 7 days immediately prior to the date of randomization and must agree to collect MFSAF data daily by ePRO device during the study collection window.

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: NCT04468984
EudraCT Number: 2020-000557-27

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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