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Therapeutic Areas: Oncology | Hematology
Disease Category: Leukemia

Trial Information

COG AALL02P2: Treatment of Late Isolated Extramedullary Relapse from Acute Lymphoblastic Leukemia (ALL) (Initial CR1>18 Months) - A Group-Wide Pilot Study

You have/Your child has been asked to participate in this research study because you have/your child has acute lymphoblastic leukemia (ALL). At least 18 months have passed since you were first diagnosed with ALL. The leukemia was in remission (had gone away), but which has now relapsed (returned) in your/your child’s central nervous system (brain and spinal cord) or testes.  The purpose of this study is to evaluate whether giving higher doses of chemotherapy (anti-cancer drugs) with less radiation therapy can bring about a remission with less long-term side effects (reactions to drugs that are not related to the reason the drugs are given).  In addition, subjects who agree may participate in additional research with the following aims:

 

1)             Bone marrow samples from subjects in relapse (at the time they enter the study) will be examined for minimal residual disease (MRD, tiny amounts of leukemia cells) that might be present in the bone marrow (soft tissue in the hollow of flat bones that produces new blood cells) to see whether MRD can predict response to treatment. 

2)             Blood samples from subjects in relapse (at the time they enter the study) will be examined to see if Host Somatic Gene Polymorphisms (HSGP, changes in genetic structure) make a difference in how subjects respond to treatment and the types of side effects they experience.

3)             Neuropsychological (NP) tests (tests of motor skills, memory, learning ability, and psychology) will be done to evaluate the effects that the disease and treatment have on thinking, learning, and behavior.  

 

You/your child will be treated on this study for about 2 years.  However, subjects will continue to have follow-up physical medical exams and blood tests for years after treatment.  Because we are interested in the long-term effects of your disease and treatment, would like to continue to find out about your/your child’s health for about 5 years after the study closes to new patients. In addition, general follow-up information will be obtained on your/your child's health once a year throughout your/your child's lifetime for as long as you/your child will allow us to.

 

Patient Inclusion/Exclusion Criteria:

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

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