Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia - Full Text View

Sponsored by:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00187005

Sponsored by:

St. Jude Children's Research Hospital

Information provided by:

St. Jude Children's Research Hospital

ClinicalTrials.gov Identifier:

NCT00187005

Purpose

The main purpose of this study is to find out if radiation to the central nervous system (CNS) can be safely omitted with early intensification of chemotherapy and chemotherapy given directly to the CNS. Another purpose is to find out if survival of children with ALL can be improved with risk-directed therapy given on this protocol.

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: Prednisone, Dexamethasone, Vincristine, Daunorubicin, PEG-L-asparaginase Drug: L-asparaginase, Methotrexate, Idarubicin, Etoposide, Cyclophosphamide, Cytarabine, Mercaptopurine	Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cyclophosphamide Cytarabine Cytarabine hydrochloride Etoposide Idarubicin Idarubicin hydrochloride Mercaptopurine 6-Mercaptopurine L-Asparaginase Daunorubicin hydrochloride Daunorubicin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Methotrexate Prednisone Vincristine sulfate Vincristine Etoposide phosphate Pegaspargase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

To determine if CNS irradiation can be safely omitted with early intensification of systemic and intrathecal chemotherapy. [ Time Frame: Unable to determine ]

Enrollment:	53
Study Start Date:	July 1998
Study Completion Date:	July 2002
Primary Completion Date:	July 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Prednisone, Dexamethasone, Vincristine, Daunorubicin, PEG-L-asparaginase See Detailed Description section for details of treatment interventions. Drug: L-asparaginase, Methotrexate, Idarubicin, Etoposide, Cyclophosphamide, Cytarabine, Mercaptopurine See Detailed Description section for details of treatment interventions.

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Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of non-B-cell leukemia by immunophenotyping (e.g. T-cell, B-cell precursor, or acute undifferentiated leukemia)
Ages less than or equal to 18 years of age
One week or less of prior therapy, limited to glucocorticoids, vinca alkaloids, emergency radiation therapy to the mediastinum and one dose of intrathecal chemotherapy Exclusion Criteria
Participants greater than 18 years of age

Responsible Party:	St. Jude Children's Research Hospital ( Ching-Hon Pui, MD / Principal Investigator )
Study ID Numbers:	TOTXIV
Study First Received:	September 12, 2005
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00187005
Health Authority:	United States: Food and Drug Administration

United States, Tennessee
St.Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105