Research

Acute Lymphoblastic Leukemia Chemoimmunotherapy with Epratuzumab – Pilot and Phase II

Chemoimmunotherapy with Epratuzumab for Children with Relapsed CD22-Positive Acute Lymphoblastic Leukemia

Protocol Description

This Children’s Oncology Group Pilot and Phase II trial is being done to find out if the drug epratuzumab, when given with chemotherapy, is effective for treating children with acute lymphoblastic leukemia (ALL) that has come back after treatment. Epratuzumab is a monoclonal antibody, a type of protein found in the immune system. Monoclonal antibodies can block the ability of cancer cells to grow and spread, while others kill cancer cells or carry cancer-killing substances to them.

Study Level: Pilot and Phase II

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, from age 2 to 31, who have been diagnosed with B-cell precursor ALL that has relapsed with At least 25 percent expression of CD22 by immunophenotyping.
Males: Ages 2 to 31 years
Females: Ages 2 to 31 years

Requirements
Treatment consists of 3, 36-day blocks of chemotherapy given in the outpatient clinic. A total of 14 drugs will be given to participants in this study, including the experimental drug epratuzumab. One group will receive epratuzumab once a week and one will be given the drug twice a week.
Frequency of visits: Initial treatment of epratuzumab requires admittance to hospital for observation. Outpatient visits vary from daily to weekly over the three blocks.
Duration: Approximately 15 weeks with participants followed for about 5 years after the study closes.

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ADVL04P2)
National Cancer Institute
Third Party

Additional Resources
Study Description at National Institutes of Health