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NCCN Guidelines for Patients



Acute Lymphoblastic Leukemia, Version 1.2017


Cancer treatments

Clinical trials

Part 4 describes the main treatments

that are used for ALL. Knowing what a

treatment is will help you understand your

treatment options listed in the Treatment

guide in Part 5. There is more than one

treatment for ALL.

Clinical trials

Clinical trials are a very important treatment option

for ALL. New tests and treatments aren’t offered to

the public as soon as they’re made. They first need

to be studied. A clinical trial is a type of research that

studies a test or treatment.

Clinical trials study how safe and helpful tests and

treatments are. When found to be safe and helpful,

they may become tomorrow’s standard of care.

Because of clinical trials, the tests and treatments in

this book are now widely used to help people with

ALL. Future tests and treatments that may have

better results than today’s treatments will depend on

clinical trials.

Clinical trials are an important treatment option

for people with ALL. Doctors are still studying

what treatments work best for ALL. NCCN experts

recommend that all patients with ALL receive

treatment on a clinical trial if possible. Receiving

treatment on a clinical trial has been shown to

improve outcomes.

New tests and treatments go through a series of

clinical trials to make sure they’re safe and work.

Without clinical trials, there is no way to know if a test

or treatment is safe or helpful. Clinical trials are done

in four steps, called phases.

Some examples of the four phases of clinical trials

for treatment are:



Phase I

trials aim to find the best dose and way

to give a new drug with the fewest side effects.



Phase II

trials assess if a drug works to treat a

specific type of cancer.



Phase III

trials compare a new drug to the

standard treatment.



Phase IV

trials test new drugs approved by the



ood and




dministration) in

many patients with different types of cancer.

Joining a clinical trial has benefits. First, you’ll have

access to the most current cancer care. Second, you

will receive the best management of care. Third, the

results of your treatment—both good and bad—will

be carefully tracked. Fourth, you may help other

people who will have cancer in the future.

Clinical trials have risks, too. Like any other test or

treatment, there may be side effects. Also, new tests

or treatments may not help. Another downside may

be that paperwork or more trips to the hospital are


To join a clinical trial, you must meet the conditions

of the study. Patients in a clinical trial often have a

similar cancer type and general health. This is to

know that any progress is because of the treatment

and not because of differences between patients.

To join, you’ll need to review and sign a paper called

an informed consent form. This form describes the

study in detail. The study’s risks and benefits should

be described and may include others than those

described above.