ReSEARCH STUDY

Do you have a patient with myelofibrosis?

Learn about our research studies of an investigational medication targeting myelofibrosis.

transforming lives Myelofibrosis Research
transforming lives Myelofibrosis Research

Our Studies

Patients who are diagnosed with myelofibrosis will experience constitutional symptoms, splenomegaly, and patients with higher risk disease are at an increased risk of transformation to acute myeloid leukemia (AML), and a shortened life expectancy. As an acquired clonal Philadelphia chromosome negative myeloproliferative neoplasm, 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), that is a potentially curative therapy, currently available 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 three research studies to evaluate an investigational agent called navitoclax in patients with myelofibrosis. 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. Patients 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 have not been established.

Locations

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

      Connect

      If you would like to learn more about the AbbVie myelofibrosis 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 agent (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 have not been established.

      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.