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About the QuANTUM-R Study

The QuANTUM-R Study is a clinical trial for patients with FLT3-ITD positive AML that has returned (relapsed) or has failed to respond to initial chemotherapy (refractory). The study will evaluate the effectiveness of standard chemotherapy compared to quizartinib, an investigational medication that specifically targets the FLT3-ITD genetic mutation. All participants will receive either quizartinib or standard chemotherapy.

You may qualify if you:

  1. Did not respond to initial treatment OR your AML returned within 6 months after initial treatment or transplant.
  2. Have the FLT3-ITD genetic mutation.

Check with your doctor if you’re unsure whether or not you have the FLT3-ITD genetic mutation. If you meet initial qualifications for the clinical trial, you will be tested for the mutation during the screening process that will occur at the study site. If you are considering a stem cell transplant or have already had one, you may still be eligible to participate in the clinical trial.

What to expect when you participate in the study.

If, after the screening process, it is determined that you qualify to participate in the clinical trial, the study doctor will examine you and inform you about the risks and benefits of participating in a clinical trial. You will also be asked to sign an informed consent form, so you can be enrolled in the clinical trial.

Once enrolled in the clinical trial, you will receive instructions about your treatment plan, which will be divided into 28-day periods or cycles. You may be asked to visit the study center approximately four times during the first 28-day cycle. You will continue to receive study medication until the study ends (as long as you do not have any serious side effects or your AML does not worsen).

You will need to inform the study doctor or other study center staff members about any side effects you may have, and do your best to follow directions from the study doctor and other staff members.

For more information or to see if you qualify, call 1-844-432-3892 Monday thru Friday 9AM – 6PM ET

Why Participate?

If you qualify and enroll in the QuANTUM-R Study you:

  • Will receive either the investigational medication or standard forms of chemotherapy used in treating AML.
  • Will receive all study-related medication and medical care at no cost.
  • May be reimbursed for time and travel.

The QuANTUM-R Study may help improve the way AML is treated in the future. Data obtained during such clinical trials often answers important questions to help move research forward. The National Comprehensive Cancer Network (NCCN) recommends that you speak with your doctor to see if a clinical trial may be right for you. 1

Visit http://www.cancer.gov/about-cancer/treatment/clinical-trials to learn more about clinical trials.

1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Myeloid Leukemia Version 1.2015. © 2014 National Comprehensive Cancer Network, Inc. Available at NCCN.org. Accessed February 4, 2016.

For more information or to see if you qualify, call 1-844-432-3892 Monday thru Friday 9AM – 6PM ET

About AML and FLT3-ITD

Acute myeloid leukemia (AML) is the most common type of acute leukemia in adults. It begins in the bone marrow and moves into the blood. “Acute” means the cancer can progress quickly and can be fatal if not treated. “Myeloid” refers to the type of cell the cancer starts from.

About 30% of people with AML have a genetic mutation known as FLT3-ITD. People with this mutation are much more likely to have a relapse or often fail to respond to initial chemotherapy. This makes the disease more difficult to treat. However, new drugs that target the FLT3-ITD mutation are currently being developed through clinical trials.

Once diagnosed, the goal of initial treatment is to:

  1. Eliminate as many AML cells as possible, and
  2. Return blood count to normal levels

This is often accomplished through chemotherapy, radiation or a bone marrow transplant.

For more information or to see if you qualify, call 1-844-432-3892 Monday thru Friday 9AM – 6PM ET

Frequently Asked Questions (FAQs)

Frequently Asked Questions About the QuANTUM-R Study

Why is this clinical trial being done?

This clinical trial will evaluate the effectiveness of an investigational medication called quizartinib, which is being developed to treat acute myeloid leukemia. The trial will compare the effectiveness of quizartinib to standard forms of chemotherapy.

How do I know if I can participate in this clinical trial?

In order to participate in the QuANTUM-R Study, you must meet two basic requirements:

  • Have AML that did not respond to initial treatment OR your AML returned within 6 months after initial treatment or transplant
  • Have AML with the FLT3-ITD genetic mutation

There are additional requirements that the clinical trial doctor can discuss with you in more detail during the screening process. If you are interested in participating and meet the basic requirements, the clinical trial doctor can bring you in for a screening visit where additional evaluations may be done.

What can I expect if I participate in this clinical trial?

If you qualify and decide to participate, your treatment will be divided into 28-day periods, called cycles. You will come to the study center approximately four times a month during the first cycle; up to two times for additional cycles. You will continue to receive treatment as long as you do not have serious side effects or your leukemia does not get worse, or until the study ends.

You will need to tell the study doctor or other study center staff members about any side effects you may have, and do your best to follow directions from the study doctor and other staff members.

What are the chances of receiving quizartinib?

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. Two out of three patients will receive quizartinib, and one out of three will receive standard chemotherapy.

How does having the FLT3-ITD genetic mutation affect my AML treatment?

Approximately 30% of all patients with AML have the FLT3-ITD genetic mutation. This particular genetic mutation makes AML more difficult to treat and more likely to come back after initial treatment.

Who is conducting this clinical trial?

The QuANTUM-R Study is being conducted by trained and licensed doctors at approximately 150 hospitals worldwide.

Will I have to pay for anything if I participate in this clinical trial?

If you qualify for this clinical trial, all study-related medical exams and study-related medication will be provided to you at no cost.

How many people will participate in this clinical trial?

About 350 AML patients may take part.

What are the risks of being in this clinical trial?

There are risks to taking part in any clinical trial. One risk is that you may get a drug or dose of a drug that does not help treat your disease, or that makes your condition worse. Another risk is that there may be side effects. The clinical trial staff will discuss all of the possible risks and potential benefits in detail with you before you decide to participate.

What happens after the clinical trial?

After the clinical trial is complete, all of the information is collected and analyzed to help determine the study medication’s effectiveness.

Do I need the permission of my primary care doctor or hematologist/oncologist to participate?

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 study doctor for more information at any time.

What do I need to tell my doctor if I’m interested in participating?

If you are interested in participating in the QuANTUM-R Study, share this study website with your doctor, so he/she can inform you about whether or not you may qualify. If it seems like you may qualify, your doctor may refer you to the study doctor who is conducting the clinical trial.

How close to a study site do I need to be to participate?

You need to be close enough that you are able to attend all study visits approximately four times a month during the first cycle; up to two times for additional cycles. You will continue to receive treatment as long as you do not have serious side effects or your leukemia does not get worse, or until the study ends.

Will I be paid for participating?

You will not be paid for participating in this study, but certain travel expenses may be reimbursed.

Who is sponsoring this research study?

Daiichi Sankyo, Inc. is the sponsor.

Frequently Asked Questions About Clinical Trials

What is a clinical trial?

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.

Is participation in a clinical trial voluntary?

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.

What is informed consent?

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.

What is an investigational medication?

An investigational medication is a drug that is currently being studied by researchers and not yet approved for use in the treatment of a specific medical condition.

What happens to my personal information?

Your personal information will not be shared with anyone who is not directly associated with this clinical trial without your permission (except as required by law).

Who oversees clinical trials?

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.

Who can participate in a clinical trial?

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.

To speak to a study representative who can help answer your questions and provide more information about how you or your loved one may qualify, call

1-844-432-3892 Monday thru Friday 9AM – 6PM ET