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

Conditions

Leukemia, other

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

This phase III ;trial ;is studying giving lestaurtinib together with combination chemotherapy to see how well it works compared to combination chemotherapy alone in treating ;infants with ;newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells or by stopping them from dividing. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with lestaurtinib may kill more cancer cells.


Participation Guidelines

Age:
1 Weeks - 1 Years
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • Patients must be enrolled on a 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 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 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, FDA, and NCI requirements for human studies must be met
Sponsor:
Children's Oncology Group (The)
Dates:
06/11/2013
Last Updated:
Study HIC#:
1305012077