High risk B-precursor acute lymphoblastic leukemia

eagle-i ID

Resource Type

Properties

1. Intervention

   Dexamethasone

2. Intervention

   Prednisone

3. Intervention

   Methotrexate

4. Additional Topic(s)

   Minimal residual disease (MRD)

5. Resource Description

   In earlier studies different therapies have been used to treat patients with high risk acute lymphoblastic leukemia (ALL). Approximately 70% of high risk patients will be cured with the best available therapies. The goal of this study is to increase this cure rate without increasing side effects of the therapy. The experimental treatments being tested here are based on information we have learned from earlier studies. This study will use a known chemotherapy regimen that has been very effective for treating children with high risk ALL and test whether two changes to this treatment can cure more patients without increasing side effects: The aim of the first change is to test two steroid drugs: whether 14 days of dexamethasone is tolerated without an increased number of severe side effects and is better than 28 days of prednisone (standard treatment) in decreasing the number of leukemia cells during the first month of treatment. The aim of the second change is to determine whether giving higher doses of methotrexate, another cancer fighting drug, will work better than giving it on a schedule that starts with a lower dose and increases with each of the later doses during a middle phase of treatment. Results from previous studies have shown that patients can be separated into two groups based on their response to the first month of treatment. Rapid Early Responders (RER) respond quickly to treatment. Slow Early Responders (SER) respond to treatment more slowly. In this study those patients that are SER will be assigned to receive more courses of heavier treatment that those patients that are considered RER, since SER are at greater risk of the leukemia returning. Minimal Residual Disease (MRD) is the measurement of very small amounts of leukemia cells. We know from previous studies that this measurement can be an important indicator of how well a patient is likely to do on therapy. By measuring the MRD level on Day 29 we hope to find out that it will be sensitive enough to identify which patients need more intense treatment. In this study RER patients will include those with a negative MRD result on Day 29 of therapy, and SER patients will include those with a positive MRD result on Day 29 of therapy.

6. Contact

   Berenberg, Jeffrey

7. PI

   Wilkinson, Robert, M.D.

8. Topic

   precursor B lymphoblastic lymphoma/leukemia

9. Study Population

   Patients with ALL between ages 1 year and 30 years of age

10. Website(s)

    http://www.curesearch.org/ArticleView2.aspx?id=7288&l=8673

11. Funded by

    Children's Oncology Group

12. Phase

    Phase 3 clinical trial

13. Performed by

    Clinical Protocol & Data Management Shared Resource