Acute Lymphoblastic Leukemia Risk-Directed Therapy for Infants – Phase III

Risk Directed Therapy for Infants with Acute Lymphoblastic Leukemia: Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition

Protocol Description

The primary goal of this Children’s Oncology Group Phase III study is to determine if the drug lestaurtinib, given together with combination chemotherapy, is better than combination chemotherapy alone in treatment of infants with newly diagnosed acute lymphoblastic leukemia (ALL). Lestaurtinib is one of a new class of medicines that is able to “turn off” an abnormal cancer-causing gene called “FLT3.”

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, up to 1 year old, with newly diagnosed ALL or acute undifferentiated leukemia.
Males: Through 12 months of age
Females: Through 12 months of age

This study includes three separate arms, stratified according to severity of the individual case. All begin with standard 5-week induction chemotherapy after which the risk group is determined - Standard risk and high-risk. High-risk participants are divided into those who will receive lestaurtinib or not in their treatment. Treatment phases for all groups continue with induction intensification, reinduction, consolidation and two continuation phases for a total of 104 weeks of therapy.
Duration: 104 weeks with participants followed for about 10 years.

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study AALL0631
National Cancer Institute
Cephalon Inc.

Additional Resources
Study Description at National Institutes of Health

Primary Investigator(s)

A. Kim Ritchey, MD

Contact Information

For additional information, please contact:
Jill Visnich

Last Update
February 17, 2014
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Last Update
February 17, 2014