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Myelofibrosis Research Study by AbbVie

In the randomized open-label Phase 3 TRANSFORM-2 study, the investigational agent (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
  • Currently have Intermediate-2 or High-Risk myelofibrosis
  • Have received prior treatment with a JAK-2 inhibitor therapy
  • 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 a multi-part clinical research study for adults with different types of blood and bone marrow conditions called Myelofibrosis (MF), Essential thrombocythemia (ET), Polycythemia vera (PV) or Chronic myelomonocytic leukemia (CMML). This information will be focusing on two parts of the study, Parts 3 and 4. You can learn more about Parts 3 and 4 of the study by reviewing the information below.

Part 3: The main purpose of Part 3 is to understand the effects of the investigational medicine (navitoclax) on the heart (specifically electrocardiogram measurements).

Part 4: The main purpose of Part 4 of is to understand the effects of the investigational drug (navitoclax) on the metabolism (how the body changes food into energy) and pharmacokinetics (how much of the investigational drug is absorbed into the blood and how the body handles the investigational drug). In this study, navitoclax will be administered either given alone (Part 3) or in combination with the anti-inflammatory pain reliever drug Celecoxib (Celebrex) (Part 4) which will be given only on Days 1 and 7. The study is for individuals requiring new treatment when previous treatment did not work, could not be tolerated or the individual declined to receive standard treatments.

Eligibility Criteria

Part 3 and Part 4 (Participants in US and Europe):

  • Part 3 Only: At screening or baseline (pre-dose on Day 1), participant has QT interval corrected for heart rate (QTc) interval by Fridericia’s correction (QTcF) <=470 msec.
  • Participants with a documented diagnosis of primary or secondary MF, ET, PV or chronic myelomonocytic leukemia (CMML) as defined by the WHO classification.
  • Participants must be requiring treatment and have failed or are intolerant to at least one prior therapy or who refuse standard therapy.
  • ECOG performance status <= 2.
  • Must have adequate bone marrow, kidney, liver and hematology blood values as detailed in the study protocol

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

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