Trial Information

Summary: COG AALL0331: Standard Risk B-Precursor Acute Lymphoblastic Leukemia

Induction Therapy

 You have/Your child has been asked to participate in this research study because you have/your child has a cancer of the white blood cells called acute lymphoblastic leukemia (ALL). Your/Your child’s ALL is classified as Standard Risk (SR) because your/your child’s white blood cell count is less than 50,000/microliters and you are/your child is at least one year old and less than ten years old.  In addition, you are/your child is participating on IRB #03186 - COG #AALL03B1: CLASSIFICATION OF ACUTE LYMPHOBLASTIC LEUKEMIA. 

The treatment given on Part I of the study, called Induction, is the current recommended treatment for SR ALL.  The purpose of this part of the study is to collect more information on ALL and the effects of Induction treatment. 

While receiving Induction treatment, information will be collected for IRB #03186 to classify your/your child’s subtype of ALL.  Your/Your child’s treatment on Part I of IRB #05062 will last 5-7 weeks.  At the end of Induction, you/your child will be asked to participate in Part II, post-induction treatment, of this study.  Part II involves a randomization (like flipping a coin) according to your/your child’s subtype of ALL.  Neither you/your child nor the researcher will choose the treatment group.

Post-Induction Intensification for Children with Standard Risk - Average Acute Lymphoblastic Leukemia

You have/Your child has been asked to take part in this research study because you have/your child has the subtype of acute lymphoblastic leukemia (ALL) called Standard Risk-Average (SR-Avg) ALL.  The purpose of this research study is to compare standard post-induction treatment for SR-Avg ALL to three experimental post-induction treatments in terms of event-free survival.  If you are/your child is female, therapy will last around 2½ years.  If you are/your child is male, therapy will last around 3½ years because males require longer maintenance therapy. Routine follow-up examinations will be done at various times after you have/your child has completed therapy.  In addition, general follow-up information will be obtained on your/your child’s health status once a year from completion of therapy until ten years after the study closes.

Post-Induction Intensification for Children with Standard Risk – High Acute Lymphoblastic Leukemia

You are/Your child is being asked to take part in this study because you have/your child has the subtype of acute lymphoblastic leukemia (ALL) called Standard Risk-high (SR-high) ALL. The purpose of this study is to improve the outcome by identifying additional high-risk patients by day 29 minimal residual disease for treatment with fully Augmented (intensified) therapy.  This study is also being done to collect information about the effect of this treatment, both the good and the bad, on children with your/your child’s subtype ALL.  If you are/your child is female, therapy will last around 2½ years.  If you are/your child is male, therapy will last around 3½ years because males require longer maintenance therapy. Routine follow-up examinations will be done at various times after you have/your child has completed therapy.  In addition, general follow-up information will be obtained on your/your child’s health status once a year from completion of therapy until ten years after the study closes.

Patient Inclusion/Exclusion Criteria:

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

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Trial listings updated: June 2, 2008 at 2:50:54 PM