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

Sponsors and Collaborators:	St. Jude Children's Research Hospital National Institutes of Health (NIH)
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00549848

Purpose

The primary objective of this study (TOTXVI) is to compare the clinical benefit, the pharmacokinetics, and the pharmacodynamics of polyethylene glycol-conjugated (PEG) asparaginase given in higher dose (HD PEG) versus those of PEG-asparaginase given in conventional dose (CD PEG) during the continuation phase.

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine Drug: Clofarabine, Methotrexate, Mercaptopurine, Dexamethasone, Etoposide, Dasatinib	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

Resource links provided by NLM:

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

Drug Information available for: Dexamethasone Cyclophosphamide 6-Mercaptopurine Prednisone Vincristine Methotrexate Daunorubicin Doxorubicin Daunorubicin hydrochloride Etoposide Dexamethasone acetate Doxiproct plus Clofarabine Pegaspargase Dasatinib Cytarabine Thioguanine Dexamethasone Sodium Phosphate Mercaptopurine L-Asparaginase

U.S. FDA Resources

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

Primary Outcome Measures:

To compare the distributions of continuous complete remission of patients randomized on the first day of continuation phase to receive higher dose PEG-asparaginase or to receive conventional dosing [ Time Frame: 8-9 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	420
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2019
Estimated Primary Completion Date:	November 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HD PEG	Drug: Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine See Detailed Description section for details of treatment interventions. Drug: Clofarabine, Methotrexate, Mercaptopurine, Dexamethasone, Etoposide, Dasatinib See Detailed Description section for details of treatment interventions.
CD PEG	Drug: Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine See Detailed Description section for details of treatment interventions. Drug: Clofarabine, Methotrexate, Mercaptopurine, Dexamethasone, Etoposide, Dasatinib See Detailed Description section for details of treatment interventions.

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

Participant has a confirmed diagnosis of precursor B-cell or precursor T-cell acute lymphocytic leukemia (ALL) by immunophenotyping
Participant is less then or equal to 18 years of age
Participant has received one week or less of prior treatment

Exclusion Criteria:

Participants with prior therapy, other than that listed above
Pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549848

Contacts

Contact: Sima Jeha, MD

1-866-278-5833

info@stjude.org

Locations

United States, Tennessee
St. Jude Children's Research Hospital	Recruiting
Memphis, Tennessee, United States, 38105
Principal Investigator: Sima Jeha, MD

Sponsors and Collaborators

St. Jude Children's Research Hospital

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Sima Jeha, MD

St. Jude Children's Research Hospital

More Information

Additional Information:

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	St. Jude Children's Research Hospital ( Sima Jeha, MD / Principal Investigator )
Study ID Numbers:	TOTXVI
Study First Received:	October 25, 2007
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00549848 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:

Leukemia

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antimetabolites
Dexamethasone
Daunorubicin
Prednisone
Leukemia, Lymphoid
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Folate
Antiemetics
6-Mercaptopurine
Cyclophosphamide
Hormones
Etoposide phosphate

Vitamin B9
Anti-Bacterial Agents
Leukemia
Pegaspargase
Dasatinib
Methotrexate
Alkylating Agents
Lymphoma
Etoposide
Dexamethasone acetate
Cytarabine
Acute Lymphoblastic Leukemia
Clofarabine
Asparaginase
Immunoproliferative Disorders

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Hormones
Pegaspargase
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Thioguanine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Neoplasms
Antimetabolites
Daunorubicin
Leukemia, Lymphoid
Immunologic Factors
Antineoplastic Agents
Cyclophosphamide

ClinicalTrials.gov processed this record on September 10, 2009