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Clinical Trial COGAALL0631


A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy =/+ FLT3 Inhibition

Principal Investigator(s)

Haydar Frangoul


  • Protocol No. COGAALL0631
  • Open Date: 09/09/2008
  • Staging: Phase III
  • Age Group: Children
  • Scope: National
  • Objective: To compare the 3-year event-free survival (EFS) of infants with MLL-R ALL randomized to treatment with a modified P9407 chemotherapy backbone with or without the FLT3 inhibitor lestaurtinib.
  • Disease Sites: Pediatrics; Leukemia
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT00557193
  • Secondary Protocol No: AALL0631


None Provided.


Ages Eligible for Study:N/A to 1 Year
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Patients must be enrolled on a Children's Oncology Group (COG) ALL Classification Study (AALL08B1) prior to enrollment on AALL0631
• Patients must be newly diagnosed with acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia (AUL); patients with T-cell ALL are eligible; patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominately lymphoid
• Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible
• Patients with Down syndrome are NOT eligible
• Patients must be previously untreated with the exception of steroids and intrathecal chemotherapy; no other systemic chemotherapy may have been administered; patients receiving prior steroid therapy are eligible for study; any amount of steroid pretreatment will not affect initial induction assignment as long as the patient meets all other eligibility criteria; IT chemotherapy per protocol is allowed for patient convenience at the time of the diagnostic bone marrow or venous line placement to avoid second lumbar puncture; (note: the central nervous system [CNS] status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); systemic chemotherapy must begin within 72 hours of this IT therapy
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met