Trial Information

COG #AALL0434: Intensified Methotrexate, Nelarabine (Compound 506U78; IND #52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia

Part 1 Induction You have/your child has been asked to participate in this research study because you have/your child has been diagnosed with T-cell Acute Lymphoblastic Leukemia (ALL). The purpose of Part I of this study is to collect more information on ALL and the effects of Induction treatment. During and at the end of Induction, test results will be collected for the ALL Classification Study IRB#03186/AALL03B1 for which you have/your child has already signed a consent form. These tests will be done to find out how well the treatment is working and how strong the rest of the treatment needs to be to keep the leukemia in remission. After your/ your child’s T-cell ALL risk category and response to this Induction therapy is known, you/your child will be asked to participate in Part II, post-induction treatment.

The treatment given on Part I of this study, called Induction, will last five weeks. After your/your child’s treatment on this study is over, your/your child’s medical condition will be followed with routine examinations. Medical information will be collected from you/your child about once a year for 10 years from the time you/your child begin participation in the study.

Part 2 Failed Induction - You have/your child has been asked to participate in this research study because you have/your child has been diagnosed with T-cell Acute Lymphoblastic Leukemia (ALL). You have/your child has currently completed the Induction treatment stage of therapy and have not gone into remission. The number of leukemia cells in the bone marrow is more than 1 in 4. The purpose of this part of the study is to evaluate the addition of the experimental drug Nelarabine to 4 courses of standard chemotherapy for ALL that has failed Induction in terms of safety and effectiveness at causing remission (no evidence of disease by standard clinical tests).

If you are/your child is female, this part II post Induction therapy will last around 2¼ years. If you are/your child is male, post Induction therapy will last around 3¼ years because males require longer maintenance therapy. After your/your child’s treatment on this study is over, your/your child’s medical condition will be followed with routine examinations. Medical information will be collected from you/your child about once a year for 10 years from the time you/your child began participation in the study.

Part 2 High Risk – You have/your child has been asked to participate in this research study because you have/your child has been diagnosed with T-cell Acute Lymphoblastic Leukemia (ALL) and you have/your child has completed the Induction treatment stage of therapy. Test results be collected for the ALL Classification Study IRB#03186/AALL03B1 showed that you are/your child has High Risk T-cell ALL because either:

a. A significant number of leukemia cells (between 1 and 5 out of 20 cells) were found in the bone marrow samples taken at the end of Induction therapy, OR
b. The minimal residual disease (MRD) testing done at the COG reference laboratory on the Day 29 bone marrow sample showed more than 1% MRD.

High Risk T-cell ALL has a higher likelihood of relapsing (returning) than other risk levels of T-cell ALL.

One purpose of this study is to compare the safety and effectiveness of standard dose methotrexate to high dose methotrexate given during the Interim Maintenance stage of therapy. Another purpose is to compare the safety and effectiveness of post-Induction treatment with and without the experimental drug, Nelarabine.

Part 2 Intermediate Risk - You have/your child has been asked to participate in this research study because you have/your child has been diagnosed with T-cell Acute Lymphoblastic Leukemia (ALL) and you have/your child has completed the Induction treatment stage of therapy. Test results be collected for the ALL Classification Study IRB#03186/AALL03B1 showed that you are/your child is in the Intermediate Risk group of T-cell ALL. This means that you/your child:
c. entered remission (less than 1 in 20 blasts in the bone marrow) at the end of Induction therapy;
d. have 1 in 100 to 1000 blasts detectable by a test called flow cytometry; and
e. are not in the Low or High Risk groups.

The purpose of this part of the study is to compare the safety and effectiveness of standard dose methotrexate to high dose methotrexate given during the Interim Maintenance stage of therapy.

If you are/your child is female, post Induction therapy will last around 2 ¼ years. If you are/your child is male, post Induction therapy will last around 3 ¼ years because males require longer maintenance therapy. After your/your child’s treatment on this study is over, your/your child’s medical condition will be followed with routine examinations. Medical information will be collected from you/your child about once a year for 10 years from the time you/your child begin participation in the study.

Part 2 Low Risk - You have/your child has been asked to participate in this research study because you have/your child has been diagnosed with T-cell Acute Lymphoblastic Leukemia (ALL) and you have/your child has completed the Induction treatment stage of therapy. Test results collected for the ALL Classification Study IRB#03186/AALL03B1 showed that you are/your child has Low Risk T-cell ALL because:
• You are/your child is between 1 and 10 years of age and had a white blood cell count of less than 50,000 when you were first diagnosed
• The leukemia responded quickly to Induction chemotherapy
• Only a very small amount of leukemia cells (less than 1 in 20) were found in the bone marrow after starting treatment (by Day 15 of Induction) and less than 1 in 1,000 leukemia cells were found in the bone marrow on Day 29 of Induction
• Leukemia cells were not found in the spinal fluid at diagnosis.

The purpose of this part of the study is to compare the safety and effectiveness of standard dose methotrexate to high dose methotrexate given during the Interim Maintenance stage of therapy.

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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