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

Purpose

The primary objective of 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, Thiogunaine Drug: Clofarabine, Methotrexate, Mecaptopurine, Dexamethasone, Etoposide, Dasatinib	Phase III

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride Etoposide L-Asparaginase Daunorubicin hydrochloride Daunorubicin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Methotrexate Prednisone Vincristine sulfate Vincristine Etoposide phosphate Dasatinib Pegaspargase Clofarabine

U.S. FDA Resources

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

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, Thiogunaine See Detailed Description section for details of treatment interventions. Drug: Clofarabine, Methotrexate, Mecaptopurine, 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, Thiogunaine See Detailed Description section for details of treatment interventions. Drug: Clofarabine, Methotrexate, Mecaptopurine, Dexamethasone, Etoposide, Dasatinib 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:

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

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

Responsible Party:	St. Jude Children's Research Hospital ( Sima Jeha, MD / Principal Investigator )
Study ID Numbers:	TOTXVI
First Received:	October 25, 2007
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00549848
Health Authority:	United States: Institutional Review Board

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

Leukemia

Study placed in the following topic categories:

Clofarabine

Dexamethasone

Asparaginase

Prednisone

Daunorubicin

Leukemia, Lymphoid

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Immunoproliferative Disorders

Vincristine

Cyclophosphamide

Etoposide phosphate

Doxorubicin

Folic Acid

Pegaspargase

Leukemia

Lymphatic Diseases

Dasatinib

Methotrexate

Lymphoproliferative Disorders

Etoposide

Lymphoma

Cytarabine

Dexamethasone acetate

Additional relevant MeSH terms:

Antimetabolites

Anti-Inflammatory Agents

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Reproductive Control Agents

Antibiotics, Antineoplastic

Hormones

Therapeutic Uses

Abortifacient Agents

Dermatologic Agents

Alkylating Agents

Nucleic Acid Synthesis Inhibitors

Neoplasms by Histologic Type

Immune System Diseases

Antineoplastic Agents, Hormonal

Gastrointestinal Agents

Enzyme Inhibitors

Folic Acid Antagonists

Abortifacient Agents, Nonsteroidal

Immunosuppressive Agents

Glucocorticoids

Pharmacologic Actions

Neoplasms

Autonomic Agents

Myeloablative Agonists

ClinicalTrials.gov processed this record on October 17, 2008

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