If you have been newly diagnosed with acute myeloid leukemia (AML), the QuANTUM-First Study may be an option for you. The study is evaluating an investigational medication for AML, given in addition to chemotherapy.To learn more or to see if you qualify
QuANTUM-First is a clinical trial for newly diagnosed patients with AML who also have a genetic mutation known as FLT3-ITD. The purpose of this study is to compare the effect of quizartinib (an investigational medication) in combination with standard chemotherapy versus standard chemotherapy alone.
If you qualify and participate in this study, you will receive standard of care treatment. This graphic shows the three phases of treatment in the clinical trial.
(up to 2 cycles)
GOAL: Reduce cancer cells
(up to 4 cycles of chemotherapy, transplant allowed)
GOAL: Further reduce cancer cells
(up to 12 cycles)
GOAL: Maintain remission and prevent relapse
Participating in the QuANTUM-First Study will not interfere with your ability to receive a stem cell transplant.
Talk to your doctor and loved ones if you are interested in the QuANTUM-First Study. Your doctor can give you more information about the clinical trial and help you decide if it’s right for you.
Participating in the QuANTUM-First Study will not delay the start of your chemotherapy treatment.To learn more or to see if you qualify
Acute myeloid leukemia (AML) is a type of cancer that begins in the bone marrow and moves into the bloodstream.
AML is usually fast growing and needs to be treated quickly. Your doctor may have already performed blood and bone marrow tests to determine the type of AML you have, as well as any changes or mutations in your genes.
In some people, having a genetic mutation known as FLT3-ITD makes the disease more difficult to treat and relapse more likely. However, new drugs that target the FLT3-ITD mutation are currently being developed through clinical trials.
The National Comprehensive Cancer Network (NCCN) recommends that you speak with your physician to see if a clinical trial may be right for you.1
For additional information about clinical trials, please see http://www.cancer.gov/about-cancer/treatment/clinical-trials
This clinical trial will evaluate the safety and effectiveness of an investigational medication called quizartinib for patients with newly diagnosed AML.
Your treatment will be assigned by a computerized process called “randomization”—a random digital ‘coin toss.’ Neither you nor the study doctor will know which treatment you receive. Half of the patients will receive quizartinib plus standard chemotherapy, and the other half will receive standard chemotherapy alone.
The QuANTUM-First Study is being conducted by trained and licensed physicians at approximately 250 hospitals worldwide
If you qualify for this clinical trial, all study-related medical exams and study-related medication would be provided to you at no cost.
Approximately 536 AML patients will take part.
The clinical trial staff will discuss all of the possible risks and potential benefits in detail with you before you decide to participate.
After the clinical trial is complete, all of the information is collected and analyzed to help determine the investigational medication’s safety and effectiveness.
No. However, it is a good idea to let your doctor know that you plan to participate in this clinical trial. With your permission, your doctor may contact the clinical trial doctor for more information at any time.
No, there is no payment involved.
Daiichi Sankyo, Inc. is the sponsor.
A clinical trial is a scientific study that evaluates the safety and effectiveness of an investigational medication. Qualified doctors, nurses and other medical professionals conduct the study. Clinical trials are performed according to government regulations, which help protect the safety and rights of participants.
New medications can only be developed through the process of clinical trials.
Your participation in any clinical trial is completely voluntary. If you decide to participate, you are always free to withdraw at any time for any reason without any penalty or effect on your future medical care.
During the informed consent process, the study doctors and nurses will describe the key facts about a clinical trial to help you decide whether or not to participate.
No study-related procedures can take place before you have signed the informed consent form. The informed consent form is not a contract, and you may withdraw from the clinical trial at any time.
An investigational medication is a drug that is currently being studied by researchers and not yet approved by the US FDA to be safe and effective for the treatment of a specific medical condition.
Your personal information will not be shared with anyone who is not directly associated with this research program without your permission (except as required by law).
To help ensure that a clinical trial is ethical and that volunteers’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols.
You must meet all of the study eligibility criteria in order to take part. To see if you qualify, the study team will review your medical history and evaluate your current medical status.
For more information or to see if you may qualify for the QuANTUM-First Study, please contact a study site.