Research

Acute Lymphoblastic Leukemia Treatment with EZN-2285 – Pilot

Intravenous EZN-2285 or Intravenous Oncaspar® in the Treatment of Patients with High-Risk Acute Lymphoblastic Leukemia

Protocol Description

This Children’s Oncology Group Pilot trial is being done to compare the effects of the drug EZN-2285 with the commonly used drug Oncaspar® for patients with high-risk acute lymphoblastic leukemia (ALL). EZN-2285 is a type of protein synthesis inhibitor, an enzyme that breaks down the amino acid asparagine and may block the growth of tumor cells that need asparagine to grow. It is very similar to Oncaspar, but has a key difference in structure. Researchers want to determine if EZN-2285 works as well as Oncaspar for children and adolescents with high risk ALL.

Study Level: Pilot

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, from age 1 through 21, who have been newly diagnosed with high-risk B-cell precursor ALL.
Males: Ages 1 through 21 years
Females: Ages 1 through 21 years

Requirements
Participants will be randomly assigned to receive either EZN-2285 or Oncaspar intravenously. The chemotherapy regimen is identical for both drugs. Treatment lasts about 2-1/2 years for female participants and 3-1/2 years for males, who require longer maintenance therapy. Patients will be followed for 10 years.
Duration: 2-1/2 years for females; 3-1/2 for males

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study AALL07P4)
National Cancer Institute
Third Party

Additional Resources
Study Description at National Institutes of Health