High-Risk Acute Lymphoblastic Leukemia Treatment with Combination Chemotherapy – Phase III

Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia, Testing Clofarabine in the Very High Risk Stratum

Protocol Description

This multicenter trial by the Children’s Oncology Group is studying how well combination chemotherapy works in treating young patients with newly diagnosed high-risk B-precursor acute lymphoblastic leukemia (HR B-ALL). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to males and females, ages 1 to 30 years, who have newly diagnosed HR B-ALL. Enrollees must also be enrolled in AALL08B1, an ALL classification study, prior to enrollment in this study.
Males and Females: Ages 1 to 30 years


Study participants will be tested to determine whether they have high-risk or very-high-risk B-ALL during the 4-week induction phase, which consists of a combination of oral, intravenous and intrathecal (IT) chemotherapy treatments over a course of 56 days. Following induction, high-risk participants are randomly assigned to one of two treatment arms for nearly 8 months of consolidation therapy, interim maintenance therapy and delayed intensification therapy, followed by maintenance therapy that repeats 12-week courses for 2 years for females and 3 years for males.

Very-high-risk patients are randomized into two treatment arms, for consolidation, interim maintenance, delayed intensification and maintenance therapy in courses that follow a similar timetable as the high-risk patients. One of the treatment arms introduces the drugs cyclophosphamide and etoposide.
Visits: Varies from daily to weekly to monthly depending on the treatment arm and stage of treatment.
Duration: Approximately 2 years and 8 months for female participants; 3 years 8 months for males, with patients followed for about 10 years.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AALL1131)
National Cancer Institute

Primary Investigator

Kim Ritchey, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN