Study:
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL)
Rationale:
Dasatinib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth
of cancer cells, either by killing the cells or by stopping them from dividing. Giving
dasatinib together with combination chemotherapy may kill more cancer cells.
Purpose:
This phase III trial is studying the side effects and how well giving dasatinib together
with combination chemotherapy works in treating young patients with newly diagnosed acute
lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some
of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to
stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Giving dasatinib together with combination chemotherapy may kill more cancer
cells.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia |
Drug: asparaginase
Drug: dasatinib
Drug: daunorubicin hydrochloride
Drug: prednisone
Drug: methylprednisolone
Drug: methotrexate
Drug: cytarabine
Drug: etoposide
Drug: ifosfamide
Biological: filgrastim
Drug: leucovorin calcium
Drug: cyclophosphamide
Drug: pegaspargase
Drug: dexamethasone
Drug: mercaptopurine
Radiation: radiation therapy
Drug: hydrocortisone sodium succinate
Drug: vincristine sulfate
Other: laboratory biomarker analysis |
Phase 3 |
Verified by
National Cancer Institute (NCI)
May, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00720109
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
William Slayton., Principal Investigator