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Refine Study for Myelofibrosis

In the open label single arm Phase 2 REFINE study, the investigational agent (navitoclax) will be administered either alone or in combination with ruxolitinib to evaluate its effect on controlling the signs and symptoms of myelofibrosis including impact on spleen size, blood counts, bone marrow fibrosis and quality of life.

Eligibility Criteria

  • 18 years of age or older
  • Have been diagnosed with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis
  • Currently have Intermediate-2 or High-Risk myelofibrosis
  • Are ineligible or unwilling to undergo stem cell transplantation
  • Have received prior treatment with ruxolitinib or another JAK-2 inhibitor for myelofibrosis, however, prior treatment is not required for all patients
  • Have splenomegaly of at least 5 cm

Navitoclax, an investigational agent, is under clinical development and is not approved by regulatory health authorities. Safety and efficacy have not been established.

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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