Trial Information

Summary: T2005-003: A Study of Bortezomib with Chemotherapy for Relapsed/Refractory Acute Lymphoblastic Leukemia

You  have/your child has been asked to participate in this research study because you have/your child has acute lymphoblastic leukemia (ALL) that has relapsed (returned after treatment), and you are/your child is 1-21 years old. Although you/your child may have responded well to chemotherapy (treatment with anti-cancer drugs) initially, the leukemia cells may have begun to resist standard leukemia treatments.  The purpose of this study is to evaluate a drug called bortezomib (Velcade®) given in combination with standard chemotherapy to treat ALL that has relapsed. 

The study is divided into two parts.  The purpose of phase I is to find the maximally tolerated dose (MTD, the highest dose of bortezomib that can be given in combination with standard chemotherapy without causing unmanageable side effects).  The purpose of phase II is to find out whether the MTD of borezomib given with standard chemotherapy is an effective therapy for the treatment of children with relapsed ALL.  Depending on when you/your child enter this study, you/your child may participate in either phase I or phase II of the study.

Your/your child’s treatment on this study will last about 1 month.  After treatment is over, your/your child’s medical condition will be followed indefinitely. 

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: October 6, 2008 at 2:44:54 PM