Do you see patients with Myeloproliferative Neoplasms or Chronic Myelomonocytic Leukemia.

Learn about our research studies of an investigational agent targeting myelofibrosis and related diseases.

transforming lives Myelofibrosis Research
transforming lives Myelofibrosis Research

Our Studies

Patients who are diagnosed with myelofibrosis will experience constitutional symptoms, splenomegaly, an increased risk of transformation to acute myeloid leukemia (AML), and a shortened life expectancy. As an acquired clonal Philadelphia chromosome negative myeloproliferative neoplasm (MPN), myelofibrosis can present in a number of ways. Patients may be diagnosed with primary myelofibrosis or secondary myelofibrosis following progression of polycythemia vera (PV) to post-PV myelofibrosis, or essential thrombocythemia (ET) to post-ET myelofibrosis. Other than hematopoietic stem cell transplantation (HSCT), current therapies are unable to control all of the clinical manifestations of myelofibrosis. Our research is focusing on potential new treatment options, including combination strategies with ruxolitinib as the backbone treatment.

We are conducting several research studies to evaluate an investigational agent called navitoclax in patients with myelofibrosis and related diseases (polycythemia vera (PV), essential thrombocythemia (ET) and chronic myelomonocytic leukemia). The primary objective of this program is to evaluate the effect of navitoclax (in most cases, in combination with ruxolitinib) on reducing spleen volume in patients with myelofibrosis. We are also conducting a research study evaluating navitoclax monotherapy in patients across MPN disease types (including myelofibrosis, PV, and ET) and CMML. Patients in all of these studies may continue on the study treatment as long as they are receiving benefit. We need help from the local medical community to help us identify qualified study participants around the world.

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

Locations

The research studies are being conducted at research centers across the globe.

      Please note, not all sites may be listed on the map. For a full list of all planned and opened sites, you may review on ClinicalTrials.gov and the links below:

      Transform 1
      Transform 2
      ENVELOP

      Connect

      If you would like to learn more about these AbbVie research studies and speak to a Principal Investigator to find out if your patients may be eligible, please complete the form below and you will be contacted by a member of the research team. Thank you for your interest.

      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.

      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
      • Have not 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 are under evaluation.

      ClinicalTrials.gov Identifier: NCT04472598

      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
      • 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 are under evaluation.

      ClinicalTrials.gov Identifier: NCT04468984

      ENVELOP is a multi-part clinical research study for adults with 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.

      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. In addition to evaluating clinical outcomes with navitoclax monotherapy in these patients, Parts 3 and 4 will evaluate the following objectives:

      Part 3: The main purpose of Part 3 is to understand the potential effect of navitoclax on the QT interval and other electrocardiogram measurements.

      Part 4: The main purpose of Part 4 of is to understand the effects of the navitoclax on the pharmacokinetics and safety of a single dose of celecoxib (a CYP2C9 substrate).

      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) <=450 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.

      ClinicalTrials.gov Identifier: NCT04041050