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Treatment for Infants with Acute Lymphoblastic Leukemia (ALL)


Leukemia - Adding Lestaurtinib to Standard Therapy for Intermediate and High Risk Infants with Acute Lymphoblastic Leukemia

Therapeutic Area Leukemias (Pediatric), Acute Lymphocytic Leukemia
Principal Investigator Michael Kelly, MD
Min Age 0 Years
Max Age 1 Years
Gender Both
Contact Jennifer Truong
More Information


This study is being done in order to find out if adding lestaurtinib to standard therapy for Intermediate and High Risk infants with ALL will result in better treatment outcomes than standard chemotherapy alone. Since lestaurtinib only targets leukemia cells, it is hoped that the side effects of lestaurtinib will be less than for standard chemotherapy drugs. There are two parts to the study

During Part 1 of the study, lestaurtinib will be given to Intermediate and High Risk patients only at a limited number of cancer treatment centers. Tufts Medical Center is NOT one of these centers. Therefore participants at Tufts Medical Center will receive the combination chemotherapy without lestaurtinib.Part 2 of this study will only be undertaken if Part 1 of the study successfully finds a dose of lestaurtinib that is safe and can turn off the FLT3 gene. In Part 2 of the study, the researchers will try to find out whether lestaurtinib is effective in infants with Intermediate and High Risk ALL.

Study Details

Inclusion Criteria

  • Patients must be < 366 days of age at the time of diagnosis; for neonates in the first month of life, patients must be > 36 weeks gestational age at the time of diagnosis.
  • Patients must be enrolled on a COG ALL Classification Study (AALL03B1 or AALL08B1) prior to enrollment on AALL0631. 
  • Patients must be newly diagnosed with acute lymphoblastic leukemia (ALL) or acute undifferentiatedleukemia (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.

Exclusion Criteria

  • Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible. 
  • Patients with Down syndrome are NOT eligible.

Study Requirements

All subjects will receive three weeks of standard Induction chemotherapy. During this regimen, 
the results of the genetic testing will become available so that subjects can be stratified into risk 
groups based on age at diagnosis and MLL gene rearrangement status as follows: 
  • Standard Risk (SR): MLL-G (germline, or non-rearranged)
  • Intermediate Risk (IR): MLL-R (rearranged), age = 90 days at diagnosis 
  • High Risk (HR): MLL-R, age < 90 days at diagnosis 
  • After Induction chemotherapy, the regimen will differ among the risk groups. 
All eligible and consenting participants will receive 3 weeks of standard Induction therapy and information will be collected about any new developments.  Subjects will then be randomized on one of three arms of chemotherapy.  The length of participation in this trial will be 2 years and participants will be followed up to 10 years. 

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