T-cell Lymphoblastic Leukemia and Lymphoma Treatment with Bortezomib – Phase III

Bortezomib on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy)

Protocol Description

This multicenter trial by the Children’s Oncology Group compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or stages II through IV T-cell lymphoblastic lymphoma (T-LLy). Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also enhance chemotherapy by making cancer cells more sensitive to the drugs. Another goal of the study is to see if cranial radiation therapy can be safely removed from treatment for most patients.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to males and females, ages 2 to 30 years, who have newly diagnosed T-ALL or T-LLy.
Males and Females: Ages 2 to 30 years

Requirements

Study participants will be randomly assigned to one of two groups. One will be given standard chemotherapy treatment. The other will receive standard chemotherapy with the addition of intravenous treatments of bortezomib at certain stages of therapy. Additionally, cranial radiation therapy will be given only to participants with high-risk T-ALL or intermediate-risk T-ALL with signs of leukemia in spinal fluid or the central nervous system.
Visits: The same number of visits as required for standard therapy
Duration: Approximately 2-1/2 to 3 years

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AALL1231)
National Cancer Institute

Primary Investigator

Jean M. Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Jean M. Tersak, MD
412-692-5055