A Clinical Trial for People with Previously Treated Myelofibrosis

Through clinical research, scientists and doctors can determine whether a new medical strategy, drug, or device is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments. Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join.

Clinical trials help determine the safety and effectiveness of treatments. A research plan, also called a protocol, is created before the trial starts. The protocol describes who can join the trial, what treatments the participants will receive, what questions the researchers will seek to answer, how long the trial will last, and how participant privacy and safety will be protected during the trial.

A clinical trial may compare a new treatment to a standard treatment option that is already available, to a placebo (an identical-looking treatment with no active ingredient), or to no intervention at all. Before you decide to join a clinical trial, the trial team will explain all of the trial details.

When new drugs are being studied as a possible treatment for patients with a disease, they are tested in stages, or “phases.” If a drug is successful in Phase 1, it moves to Phase 2. If it is successful in Phase 2, it moves to Phase 3.

Drugs that enter Phase 2 trials have already been studied in other clinical trials. Researchers have gathered information about the safety of the drug, usually in small numbers of participants.

In a Phase 2 trial, a drug is studied in a larger group. Some Phase 2 trials may include several hundred people. The goals of many Phase 2 trials are to begin to study how well a drug works as a treatment for a specific disease or condition and to learn more about the safety of the drug, including any side effects people might have when they take it.

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this website by clicking the “Check Eligibility” button.

Trial volunteers have the right to drop out of the trial at any time for any reason or no reason at all. The trial doctor or sponsor also has the right to discontinue a trial volunteer at any time for the participant’s safety or if the participant no longer meets the trial requirements.

The trial doctor and other site staff will collect your personal information. This may include:

• Your name, address, telephone number, and health insurance number, where applicable
• Your age, sex, and ethnic and racial background
• Lifestyle information
• Medical history details
• Your trial treatments and your response to these treatments
• Data resulting from testing your biological samples

All of your personal information collected for this trial will be securely stored in the trial medical records at the trial site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and government health authorities may check the trial records. This is done to make sure that the trial is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by Citeline Connect to contact you about clinical trials and related information.

To learn more, you can ask your doctor for additional information. You can also visit www.ClinicalTrials.gov and search for this trial. You can search for the trial using this number: NCT04562870.

Importance of clinical trials and diversity in clinical trials:

Clinical trials are the best tools we have to raise the standard of care for a disease. They help us learn more about what keeps us healthy, and what helps the most when we get sick.

The success of clinical trials relies on clinical trial participants, and the strongest clinical trials are those where everyone who might benefit from treatment is represented. It takes the commitment of many clinical trial participants of different ages, races, and ethnicities to understand whether a drug is safe and effective and whether it offers advantages over the current standard of care.

When you volunteer your time and effort as a clinical trial participant, you take an active role in the development of treatments that can make a meaningful difference in the lives of others.