Title (COG AALL07P1) 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)
Principal Investigator Martin Brecher, MD
Study Number 203211
Summary This is a phase 2 pilot study to determine the feasibility and safety of adding bortezomib to intensive induction chemotherapy for patients with relapsed B-precursor acute lymphoblastic leukemia (ALL), relapsed T-Cell ALL and relapsed T-lymphoblastic lymphoma (LL). Despite significant progress in the treatment and outcome of pediatric ALL/LL, the prognosis for patients who develop recurrent disease is poor. This study aims to improve outcomes in relapsed ALL by combining bortezomib with the backbone chemotherapy regimen used for treatment of relapsed ALL in COG study AALL01P2.
- Patients must be greater than 1 year of age and less than or equal to 31 years of age at the time of study enrollment.
- Patients with leukemia must have had histologic verification of the malignancy at relapse, including immunophenotyping to confirm diagnosis.
- Patients with lymphoblastic lymphoma must have measurable disease documented by clinical, radiographic, or histologic criteria. Patients must have relapsed or become refractory to conventional therapy.
- Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients greater than or equal to 16 years of age
- Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study.
- All patients must have adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function, and central nervous system function.