Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

A Phase II Pilot Trial of Bortezomib (PS-341, Velcade®, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

The aims of this study are to improve study treatment for relapsed ALL. However, LL has been shown to respond to chemotherapy in a similar way to ALL and is often treated as a leukemia. Therefore, we think that the therapy may also have an effect on LL.

This study is a Phase 2 study. A phase 2 study is done to measure the response of a disease to an experimental drug. This study is being done to find out if adding bortezomib to the standard Re-Induction therapy is a helpful and effective therapy for treating children and young adults with relapsed ALL.

 The goals of this study are:

• To measure how effective the combination of bortezomib with standard chemotherapy drugs is at treating children and young adults with relapsed ALL
• To find out what effects (good and/or bad) bortezomib, given with standard chemotherapy drugs, has on children and young adults with relapsed ALL

This study is organized by Children’s Oncology Group (COG).

Approximately 6 subjects will participate at the University of Iowa. The maximum number of people enrolled on this study is expected to be around 151. This total includes both leukemia and lymphoma subjects.