Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807)

eagle-i ID

Resource Type

Properties

1. ClinicalTrials.gov url

   http://www.clinicaltrial.gov/ct2/show/NCT00557193

2. Intervention

   Asparaginase

3. Intervention

   Cyclophosphamide

4. Intervention

   Cytarabine

5. Intervention

   Daunorubicin hydrochloride

6. Intervention

   Dexamethasone

7. Intervention

   Etoposide

8. Intervention

   Lestaurtinib

9. Intervention

   Leucovorin calcium

10. Intervention

    Mercaptopurine

11. Intervention

    Methotrexate

12. Intervention

    Methylprednisolone

13. Intervention

    Pegaspargase

14. Intervention

    Prednisone

15. Intervention

    Therapeutic hydrocortisone

16. Intervention

    Vincristine sulfate

17. Resource Description

    "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."

18. Additional Name

    Combination Chemotherapy With or Without Lestaurtinib in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

19. Contact

    Berenberg, Jeffrey

20. PI

    Wilkinson, Robert, M.D.

21. Topic

    lymphoblastic leukemia

22. Study Population

    Males and females up to 1 year old with newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia.

23. Website(s)

    http://www.cancer.gov/clinicaltrials/search/view?cdrid=573996&version=healthprofessional

24. Funded by

    Children's Oncology Group

25. Phase

    Phase 3 clinical trial

26. Performed by

    Clinical Protocol & Data Management Shared Resource