This family protocol summary is about the Children’s Oncology Group study AALL0932. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form. You can get this from your oncologist.

AALL0932 is a Phase III clinical trial. A trial is another word for a study. This study (clinical trial) is a therapeutic clinical trial. That means it is done to learn about treatment – its safety and how well it works. The purpose of a Phase III trial is to learn if a drug or treatment that is known to work in treating a type of cancer is better in some way than the standard treatment. For example, does it have better cure rates, longer control of disease, fewer or less serious side effects, or fewer days in the hospital?

AALL0932 compares several different treatments. These treatments are called study arms. Usually, one study arm is the standard or the best proven current treatment. The other study arms have some changes or additions. The new treatment is thought to be at least as good as the standard treatment. It is not known if the new treatment will be better than the standard treatment.

In a Phase III trial, each child is assigned to a study arm by a method called randomization. This is a process like flipping a coin that assures that each child has a fair and equal chance of being assigned to any of the study arms. This way the study arms can be compared fairly.

In most clinical trials, we will not know which treatment is better until all of the children taking part in the trial have completed treatment and have been getting checked for several years. If one of the treatments is found to be better or safer than the others while the trial is still going on, the trial will be stopped. All children still in the trial will be given the treatment with the best results when possible.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find additional information about participation in clinical trials at Always discuss any questions that you may have with your health care team.

Study Number


Official Title

Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)

Study Opening Date

This study opened for enrollment on August 9, 2010. This study plans to enroll 8992 patients. **The study closed to patients with B-ALL on 5/29/2015, but remains open to patients with B-LLy and patients with Down syndrome and B-ALL or B-LLy

General Patient Eligibility



Please consult your doctor to determine whether you or your child may participate in this study.

General Background and Study Goal

B-lymphoblastic leukemia (B-ALL) is the most common type of childhood cancer. Survival rates for this type of leukemia range from 80-85%. At diagnosis, patients with B-ALL are assigned to risk groups based on their age, white blood cell count and other factors. Current risk group assignment also include the response to initial treatment, meaning, how quickly the leukemia cells are destroyed. The term ‘risk’ in ‘risk group’ means the ‘risk of the leukemia cells coming back,’ so knowing the patient’s risk group helps determine what treatment is best. B-ALL patients are assigned to one of four risk groups:

Patients in the LR and AR groups can be treated on this study.

The current best B-All treatment, also called standard therapy, uses a variety of chemotherapy drugs given at different doses, schedules or intensity, depending on the risk group. Treatment is administered in 5 distinct phases, or periods of time, called:

Treatment for AR patients on AALL0932 will alter the doses or frequency of standard leukemia drugs during the maintenance phase of treatment with the goal of maintaining or improving cure rates, while reducing side effects.

Treatment for LR patients will compare 2 very different treatment arms of lower intensity treatment.

Children with lymphoblastic lymphoma are treated with “leukemia type” treatment with excellent outcomes. Patients with localized (meaning disease is limited to a restricted area) B-LLy on ALL0932 will be assigned to the standard arm of treatment, with the goal of learning more about lymphoma biology and response to treatment.

Summary of the Treatment  

Average Risk (Closed to further enrollment on 5/29/15)
AALL0932 hopes to learn if increasing the dose of methotrexate during maintenance will improve the cure rate. Another question is if two standard chemotherapy drugs, vincristine and dexamethasone, can be given less frequently without affecting the high cure rate. To answer these two questions, patients will receive one of the following treatments during maintenance:

Low Risk (Closed to further enrollment on 5/29/15)
The LR compares 2 treatment arms. Each treatment has been shown to be effective in other studies but these treatments have not yet been compared to each other.

Patients with Down syndrome
All children with Down syndrome will receive the same as the AR arm using the less frequent vincristine/dexamethasone schedule and the standard dose of methotrexate during maintenance. The goal is to standardize treatment, improve outcomes, and to assist in future studies on the biology of ALL in children with Down syndrome.

All patients will receive the standard AR treatment with vincristine/dexamethasone every 4 weeks and standard dose methotrexate during maintenance.

Please refer to the Family Handbook or the Children’s Oncology Group website: for additional information.

Special Considerations

Risks and Side Effects

Chemotherapy can cause side effects during and after treatment. All patients will be closely monitored for possible side effects of the medicines. All risks and side effects will be explained by your treatment team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the clinical trial or other aspects of care. Please refer to the consent form for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your child’s oncologist and nurses are the best source for further information.

Study Chair:
Dr. Anne Angiolillo MD
Children’s National Medical Center


Initial development Name Date
Written by (protocol nurse) Kathy Woo MSN, RN, CPNP November 18, 2015
Reviewed/approved by (PI) Anne Angiolillo MD November 19, 2015
Ongoing review
Reviewed and updated by Kathy Woo MSN, RN, CPNP February 10, 2017
January 31, 2018

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