Clinical Trial COGAALL0631
Title
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)
Details
- 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
Description
None Provided.
Eligibility
| Ages Eligible for Study: | N/A to 1 Year |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
• Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia
• T-cell ALL allowed
• Bilineage or biphenotypic acute leukemia allowed provided the morphology and immunophenotype are predominately lymphoid
• No mature B-cell ALL or acute myelogenous leukemia (AML)
• Must be < 366 days of age at diagnosis; neonates in the first month of life must be > 36 weeks gestational age at diagnosis
• Must be enrolled on protocol COG-AALL08B1 prior to enrollment on this protocol
• Previously untreated except for the following:
• Any amount of steroid pretreatment allowed, provided that the patient meets all other eligibility requirements
• Inhalation steroids are not considered as pretreatment
• Intrathecal (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
• No B-cell ALL or acute myelogenous leukemia
PATIENT CHARACTERISTICS:
• No Down syndrome
PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No concurrent chronic steroid treatment for another disease
• No other concurrent non-protocol chemotherapy or investigational therapy
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