Trial Information

COG AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)Testing Clofarabine (IND#73789, NSC# 606869) in the Very High Risk Stratum

Even though treatment success rates are very good for people with HR-ALL, some patients still have relapse of their leukemia. Therapy on this study attempts to decrease the number of people who relapse in the central nervous system. This is called CNS relapse.

The CNS is made up of the brain and spinal cord and the fluid that surrounds them. One of the ways doctors try to prevent CNS relapse is by giving some of the chemotherapy into the fluid surrounding the spine. Medicines given into the spinal fluid are given intrathecally or IT. This study looks at how well CNS relapse can be prevented in children with HR-ALL by comparing the use of 3 drugs (methotrexate, hydrocortisone, and cytosine arabinoside) given intrathecally. This is called triple intrathecal therapy or ITT. We will compare ITT to the standard use of 1 drug (methotrexate) given intrathecally (IT MTX). The use of ITT is experimental on this study. However, ITT has been given to many people will ALL and has been well tolerated. We do not know which approach is better. That is why we are doing this study.

This study also includes studies that aim to better understand the things that contribute to side effects of cancer treatment, and how to prevent them or reduce them as much as possible.

The overall goals of this study are to:

o Find out if using chemotherapy with ITT improves survival rates better than using chemotherapy with IT MTX for HR-ALL.
o Compare the effects, good and/or bad, of chemotherapy with ITT to chemotherapy with IT MTX for HR-ALL to find out which is better.

In this study, you will get either the ITT or the IT MTX. You will not get both.

Other goals of this study are:

o To better understand the effects of cancer treatment in people with HR-ALL.

Patient Inclusion/Exclusion Criteria:

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

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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Research Center Information: City of Hope

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