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.
COG # AALL1131
This study is for newly diagnosed High Risk and Very High Risk Acute Lymphoblastic Leukemia (ALL) with or without Down Syndrome. Leukemia is cancer of blood cells. It develops in the bone marrow, which is the soft, spongy center of the bones that produces the three major blood cells.
Patients must be enrolled on AALL08B1 prior to enrollment on AALL1131.
White Blood Cell Count (WBC) Criteria
- Age 1-9.99 years: WBC ³ 50 000/_L
- Age 10-30.99 years: Any WBC
- Age 1-30.99 years: Any WBC with:
- Testicular leukemia
- CNS leukemia (CNS3)
- Steroid pretreatment
Other criteria that makes a patient high risk or very high risk:
- You are 10 years of age or older;
- You have a white blood cell count of over 50 000/microliter at diagnosis;
- You are a male and have leukemia in your testes;
- You have leukemia in the spinal fluid (the fluid surrounding the brain and spinal cord) or the brain; or
- You received treatment with steroid medications, such as prednisone or dexamethasone, in the month before you were diagnosed.
VERY HIGH RISK:
- You are 13 years or older
- You had leukemia cells in your spinal fluid or brain at diagnosis
- Your leukemia has not responded quickly to Induction cancer fighting medicine (chemotherapy)
- You have genetic patterns in your leukemia cells that are specific to Very High Risk ALL
Mandy Atkinson, M.D.
Wendy McCarty, Clinical Research Coordinator
For additional information on Children's Oncology studies, please visit www.childrensoncologygroup.org .