Clinical Trial TitleStudy of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis (TRANSFORM-1)
National Clinical Trial Number:NCT04472598
Clinical Trial Protocol Description:
Myelofibrosis (MF) belongs to a group of closely related blood cancers known as “myeloproliferative neoplasms (MPNs)” in which the bone marrow cells that produce the body’s blood cells develop and function abnormally.
Ruxolitinib is an oral drug used to treat adults with certain types of primary myelofibrosis (MF), post-polycythemia vera MF, post-essential thrombocythemia MF, or polycythemia vera, and adults and children aged 12 years and older with acute graft-versus-host disease. Navitoclax blocks some of the enzymes that keep cancer cells from dying. It may kill cancer cells by blocking the production of a protein that makes cancer cells live longer and by making them more sensitive to anticancer drugs.
The purpose of this study is to evaluate how well the investigational drug (navitoclax) works and how safe it is when given in combination with ruxolitinib compared to ruxolitinib with a placebo in patients with myelofibrosis who have not been previously treated with a standard treatment such as a JAK-2 inhibitor or similar medication.
The study has two treatment arms and you will be randomly (as with the flip of a coin) assigned to either of the treatment arms. If you agree to participate in this study, you will receive either navitoclax once daily and ruxolitinib (a drug your doctor currently prescribes as standard of care for patients with myelofibrosis) twice daily (Arm A), or placebo once daily and ruxolitinib twice daily (Arm B, control) until you no longer benefit from treatment or if an unacceptable side effect occurs, with weekly visits for the first two weeks, bi-weekly visits for the next two months, and every 12 weeks thereafter until you discontinue from the study.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older and are diagnosed with a diagnosis of primary MF or secondary myelofibrosis (SMF) (post polycythemia vera [PPV]-MF or post essential thrombocythemia [PET] – MF).
- Are classified as intermediate-2 or high-risk MF.
You will be excluded from the study if any of the following criteria apply to you:
- Have received prior treatment with a JAK2 inhibitor.
- Are ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant.
- Have no clinically significant, uncontrolled medical conditions including but not limited to: Ongoing systemic infection (viral, bacterial, mycobacterial, or fungal); Febrile neutropenia.
- Are not taking medication that interferes with coagulation or platelet function except for low dose aspirin (up to 100 mg daily) and low molecular weight heparin within 3 days prior to the first dose of study drug or during the study drug treatment period.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.