myCare-204 FAQ

Q: What is the myCare-204 Trial?

The myCare-204 Trial is a prospective, randomized, multi-arm, multi-site randomized clinical trial program evaluating the efficacy and safety of Singula™ for use in treatment selection

Q: What is the purpose of the myCare-204 trial?

The purpose of this research study is to run a prospective, randomized, multi-arm, multi-site randomized clinical trial program evaluating the efficacy and safety of Singula™ for use in treatment selection

Q: What is the objective of the study

The myCare-204 Trial is designed to evaluate the relationship between Cellworks Singula™ and complete remission (CR) as the primary endpoint. Evaluations will be performed in newly diagnosed AML patients 60 years of age or older as well as in AML patients who are refractory or have relapsed. The trials secondary endpoints will include measurable residual disease (MRD). MRD is a known independent prognostic indicator in AML useful for risk stratification and treatment planning. In accordance with International Working Group (IWG) guidelines, disease-free survival (DFS) and overall survival (OS) will also be evaluated as secondary endpoints.

Q: What are the benefits of participating as a Physician?

This study may benefit participants by providing results that help the Treating Physician better understand the patient’s disease. In specific, the study results could help in understanding accuracy of disease diagnosis and better inform patient prognosis. The study results could also provide new ideas for treatment options. The Treating Physicians are also on the study team and therefore study results are available to them via the principal investigator (PI).

• Ability to select the most efficacious drug or drug combination for a patient based on a biosimulation of how a patient’s tumor profile responds to standard care drugs
• Knowledge of how an individual patient will respond to all AML standard care drugs prior to treatment. The biosimulation analyzes mutational interactions of 4,000+ networked genes to predict and rank phenotype responses to all AML Standard Care treatments
• Helps patients avoid the unnecessary side effects of therapies that will not produce a response in their specific tumor.
• Improvement of overall survival rates for patients.

Q: What are the benefits of participating as a patient?

• You may benefit from participating in this research because your treatment results could help your doctor understand the inner workings of your disease and accurately predict effective treatment for you and future patients.
• Cellworks removes the black box from the analysis for treatment selection by providing rationales that explain how your unique molecular pathways will respond to the AML Standard Care treatments.
• Knowledge of how an individual patient will respond to all AML standard care drugs and novel combinations therapies prior to treatment. The biosimulation analyzes mutational interactions of 4000+ networked genes to predict and rank phenotype responses to all AML Standard Care treatments.
• Avoid the unnecessary side effects of therapies that will not produce a response from your specific tumor.
• Improvement of complete remission, disease free survival, overall survival rates, objective remission rates and reduction in measurable residual disease for patients.

Q: What are the benefits of participating as an Institution?

• Helping patients avoid the unnecessary side effects of therapies that will not produce a response in their specific tumor.
• Improvement of complete remission, disease free survival, overall survival rates, objective remission rates and reduction in measurable residual disease for patients.
• Ability to select the most efficacious treatment within AML Standard Care treatments for each patient based on a biosimulation of how the patient’s tumor profile responds to standard care drugs.
• Knowledge of how an individual patient will respond to all AML standard care therapies prior to treatment. The biosimulation analyzes mutational interactions of 4000+ networked genes to predict and rank phenotype responses to all AML Standard Care treatments

Q: What are the risks of participation?

• The current study utilizes FDA approved treatments i.e. AML On Label Drugs.
• Nevertheless, patients participating in the current study may have unpleasant, serious, or life-threatening side effects as a consequence of the physician assigned treatment.
• Furthermore, the assigned treatments may not be effective for the study participant.
• Additionally, the protocol may require more time and attention than would a non- protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage regimens.
• Cellworks also does not provide information regarding drug toxicity. This determination will need to be made by the treating physician.
• There are possibilities of adverse events or serious adverse events due to the treatment provided. The treatment provided may involve risks which are currently unforeseeable.
• Research participants may be at greater risk of having their personal health information disclosed by participating in a research study. Every effort will be made to safeguard the identity of the study participants, as well as their de-identified data.

Q: What indications are included?

The trial is designed specifically for newly diagnosed and relapsed refractory AML patients

Q: Can a patient with another type of cancer participate?

Only AML patients are eligible to participate in the trial

Q: Who pays for the drugs during this trial?

During this trial your drugs should be obtained by the usual methods for acquiring treatments. This can include: private insurance, other clinical trials and Medicare Part D.