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

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. 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.

Study Status: Recruiting

Recruiting:
n/a

Condition Intervention Phase
Acute Undifferentiated Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Drug: asparaginase
Drug: daunorubicin hydrochloride
Drug: lestaurtinib
Drug: cyclophosphamide
Drug: pegaspargase
Drug: prednisone
Drug: methylprednisolone
Drug: dexamethasone
Drug: cytarabine
Drug: methotrexate
Biological: filgrastim
Drug: leucovorin calcium
Drug: etoposide
Drug: mercaptopurine
Drug: vincristine sulfate
Drug: hydrocortisone sodium succinate
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 3

Verified by Children`s Oncology Group July, 2013

Sponsored by: Children`s Oncology Group
Information provided by: Children`s Oncology Group
ClinicalTrials.gov identifier: NCT00557193

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Joanne Hilden., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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