Trial Information

Summary: High Risk B- Precursor Acute Lymphoblastic Leukemia Study

What is the purpose of this study?
The rate of survival continues to improve for children with high risk ALL. However, leukemia in the brain and spinal cord (CNS) has become an increasing cause of treatment failure. This study will use an established chemotherapy regimen that has been very effective for treating children with high risk ALL and test whether two different changes to the treatment can cure more patients.

Change #1: Compares 14 days of dexamethasone to 28 days of prednisone during the first month of therapy (all other treatment is the same during this time). We are doing this to find out if using dexamethasone instead of prednisone can improve survival rates without causing more serious side effects.

Change #2: Compares two different ways to give intravenous methotrexate in a two month long phase of treatment called Interim Maintenance. Both ways of giving methotrexate have been very effective in other studies, but they have never been directly compared to one another in children with high risk ALL. We are doing this to find out if using high doses of methotrexate instead of using lower doses of methotrexate on a schedule that gradually increases the dose, can keep the cancer from returning without causing more serious side effects.

In addition to the aims linked to the changes in treatment, there is an additional research goal. We would like to see if how quickly patients respond to initial therapy (reach disease remission) and how well they do following treatment can be linked to the presence or absence of very small numbers of leukemia cells in the bone marrow on Day 29 of treatment.

Who will be included in this study?
Patients who are 1 to 30 years old newly diagnosed B-precursor acute lymphoblastic leukemia may be eligible to participate in this clinical trial.

What is involved?
Female patients are expected to be on the treatment part of this study for approximately 2½ years. Because males receive longer periods of Maintenance therapy, males are expected to be on the treatment part of this study for approximately 3½ years.

After the therapy has been completed, patients will have follow-up examinations and medical tests at the following time points:

• Every month during the first year after therapy
• Every 2 months during the second year after therapy
• Every 3 months during the third year after therapy
• Every 6 months during the fourth year after therapy
• At 6-12 months during the 5th year after therapy

The following test and procedures will be performed:

• Physical exams
• Blood tests
• Tests of kidney function
• Chest X-rays
• Tests of heart function
• Tests of liver function
• Testicular biopsy: If it is questionable whether there is leukemia in one or both testes upon physical examination, a biopsy of the testes will be performed to determine if leukemia is present in the testes.
• Bone marrow aspirates and tests on bone marrow for minimal residual disease
• Spinal taps

What are the benefits?
Participants who agree to take part in this research study may or may not experience a direct medical benefit. Another possible benefit may include an increase in survival rate for patients with High Risk ALL, along with a reduction in serious side effects. Therapies similar to core PC treatment arm in this research study have been effective in controlling the spread of high risk leukemia, the achievement of a long-term remission, and possibly a cure. It is hoped that the information learned from this study will benefit other patients with high risk acute lymphoblastic leukemia in the future.

Will I get all the facts about the study?
Parents interested in having their child participate will be scheduled with a physician who will thoroughly explain all of the details of the study. The physician will review the consent form with the parent/patient and will be sure that all questions are answered. The consent form goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects will be provided to those patients interested in knowing more about the study.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.