Frequently Asked Questions – The ENVELOP Study

Frequently Asked Questions

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This research study is evaluating an investigational medication for a variety of blood and bone marrow conditions in adults. You may be able to take part in this study if you:

  • Are at least 18 years of age
  • Have been diagnosed with one of the following blood or bone marrow conditions:
    • Myeloproliferative neoplasms (MPNs):
      • Polycythaemia vera (PV)
      • Essential thrombocythaemia (ET)
      • Myelofibrosis (MF)
    • Chronic myelomonocytic leukaemia (CMML)
  • Have declined or not had success with at least one standard treatment

Additional study criteria will apply.

The ENVELOP Study will evaluate the safety and effectiveness of an investigational medication, called navitoclax, targeting cells that are not working normally in the blood and bone marrow. It is being evaluated in adults with chronic myelomonocytic leukaemia, polycythaemia vera, essential thrombocythaemia and myelofibrosis. The study will enrol about 47 participants across the United States and Europe.

Participants will take the investigational medication daily, in the morning with breakfast (or 30 minutes after the meal). During visits to the study clinic, dosing may be carried out in the morning at the clinic. Total study duration will vary for each participant depending on the response to the investigational medication.

A variety of visits to the study clinic will be required for this study, starting with one visit during the screening period (Visit 1), which may last up to 28 days. During the study treatment period, there will be more frequent study visits in the first couple of weeks, then study visits every 12 weeks until participants take their last dose of the investigational medication. After that, participants will enter the follow-up period, which includes one visit approximately 30 days after taking the last dose, then visits every six months for up to five years.

The study duration will vary for each participant depending on the response to the investigational medication.

Navitoclax, the investigational medication being studied, is a film-coated tablet that will be taken daily by mouth. It has not been approved by regulatory agencies and its safety and effectiveness are under evaluation. During this study, researchers continue to study the effectiveness of the investigational medication and monitor its side effects in a large group of study participants.

Do not discontinue any medication unless you are advised to do so by the study clinic staff or your GP.

You will not be charged anything for participating in the study.

Clinical research studies are designed in specific ways and one or more of the answers that you provided fell outside the guidelines for this study. This does not mean you will not qualify for different research studies.

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