Study:
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 (CEP-701, Lestaurtinib; IND#76431; NSC#617807)
Rationale:
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.
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.
Study Status: Recruiting
Recruiting:
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
| Condition |
Intervention |
Phase |
|
Leukemia |
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: etoposide
Drug: lestaurtinib
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: methylprednisolone
Drug: pegaspargase
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate |
Phase 3 |
Verified by
Children`s Oncology Group
November, 2012
Sponsored by: Children`s Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00557193
Study Type: Interventional
Study Design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Joanne M. Hilden, MD., Study Chair
Patrick A. Brown, MD.,