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Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

This study has been terminated.
(Toxicity)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187005
First Posted: September 16, 2005
Last Update Posted: March 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Jude Children's Research Hospital
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

Resource links provided by NLM:


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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187005


Locations
United States, Tennessee
St.Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Ching-Hon Pui, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:
Hammond TG, Hu A, Hammond JM, Relling MV, Underwood JL. Detection of point mutations on a DNA microchip Clinical Immunology Newsletter 19(12):121-6, 1999.
Pui CH, Mahmoud HH, Wiley JM, Woods GM, Leverger G, Camitta B, Hastings C, Blaney SM, Relling MV, Reaman GH. Recombinant urate oxidase for the prophylaxis or treatment of hyperuricemia in patients With leukemia or lymphoma. J Clin Oncol. 2001 Feb 1;19(3):697-704.
Pui CH, Jeha S, Irwin D, Camitta B. Recombinant urate oxidase (rasburicase) in the prevention and treatment of malignancy-associated hyperuricemia in pediatric and adult patients: results of a compassionate-use trial. Leukemia. 2001 Oct;15(10):1505-9.
Panetta JC, Yanishevski Y, Pui CH, Sandlund JT, Rubnitz J, Rivera GK, Ribeiro R, Evans WE, Relling MV. A mathematical model of in vivo methotrexate accumulation in acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2002 Nov;50(5):419-28. Epub 2002 Sep 24.
Coustan-Smith E, Sancho J, Behm FG, Hancock ML, Razzouk BI, Ribeiro RC, Rivera GK, Rubnitz JE, Sandlund JT, Pui CH, Campana D. Prognostic importance of measuring early clearance of leukemic cells by flow cytometry in childhood acute lymphoblastic leukemia. Blood. 2002 Jul 1;100(1):52-8.
Coustan-Smith E, Sancho J, Hancock ML, Razzouk BI, Ribeiro RC, Rivera GK, Rubnitz JE, Sandlund JT, Pui CH, Campana D. Use of peripheral blood instead of bone marrow to monitor residual disease in children with acute lymphoblastic leukemia. Blood. 2002 Oct 1;100(7):2399-402.
Yeoh EJ, Ross ME, Shurtleff SA, Williams WK, Patel D, Mahfouz R, Behm FG, Raimondi SC, Relling MV, Patel A, Cheng C, Campana D, Wilkins D, Zhou X, Li J, Liu H, Pui CH, Evans WE, Naeve C, Wong L, Downing JR. Classification, subtype discovery, and prediction of outcome in pediatric acute lymphoblastic leukemia by gene expression profiling. Cancer Cell. 2002 Mar;1(2):133-43.
Panetta JC, Wall A, Pui CH, Relling MV, Evans WE. Methotrexate intracellular disposition in acute lymphoblastic leukemia: a mathematical model of gamma-glutamyl hydrolase activity. Clin Cancer Res. 2002 Jul;8(7):2423-9.
Cheok MH, Yang W, Pui CH, Downing JR, Cheng C, Naeve CW, Relling MV, Evans WE. Treatment-specific changes in gene expression discriminate in vivo drug response in human leukemia cells. Nat Genet. 2003 May;34(1):85-90. Erratum in: Nat Genet. 2003 Jun;34(2):231.
Kishi S, Griener J, Cheng C, Das S, Cook EH, Pei D, Hudson M, Rubnitz J, Sandlund JT, Pui CH, Relling MV. Homocysteine, pharmacogenetics, and neurotoxicity in children with leukemia. J Clin Oncol. 2003 Aug 15;21(16):3084-91.
Hinds PS, Gattuso JS, Fletcher A, Baker E, Coleman B, Jackson T, Jacobs-Levine A, June D, Rai SN, Lensing S, Pui CH. Quality of life as conveyed by pediatric patients with cancer. Qual Life Res. 2004 May;13(4):761-72.
Hak LJ, Relling MV, Cheng C, Pei D, Wang B, Sandlund JT, Rubnitz J, Pui CH. Asparaginase pharmacodynamics differ by formulation among children with newly diagnosed acute lymphoblastic leukemia. Leukemia. 2004 Jun;18(6):1072-7.
Neale GA, Coustan-Smith E, Stow P, Pan Q, Chen X, Pui CH, Campana D. Comparative analysis of flow cytometry and polymerase chain reaction for the detection of minimal residual disease in childhood acute lymphoblastic leukemia. Leukemia. 2004 May;18(5):934-8.
Cheng Q, Wu B, Kager L, Panetta JC, Zheng J, Pui CH, Relling MV, Evans WE. A substrate specific functional polymorphism of human gamma-glutamyl hydrolase alters catalytic activity and methotrexate polyglutamate accumulation in acute lymphoblastic leukaemia cells. Pharmacogenetics. 2004 Aug;14(8):557-67.
Rubnitz JE, Lensing S, Zhou Y, Sandlund JT, Razzouk BI, Ribeiro RC, Pui CH. Death during induction therapy and first remission of acute leukemia in childhood: the St. Jude experience. Cancer. 2004 Oct 1;101(7):1677-84.
Glass JO, Reddick WE, Reeves C, Pui CH. Improving the segmentation of therapy-induced leukoencephalopathy in children with acute lymphoblastic leukemia using a priori information and a gradient magnitude threshold. Magn Reson Med. 2004 Dec;52(6):1336-41.
Cox CL, Lensing S, Rai SN, Hinds P, Burghen E, Pui CH. Proxy assessment of quality of life in pediatric clinical trials: application of the Health Utilities Index 3. Qual Life Res. 2005 May;14(4):1045-56.
Reddick WE, Glass JO, Helton KJ, Langston JW, Xiong X, Wu S, Pui CH. Prevalence of leukoencephalopathy in children treated for acute lymphoblastic leukemia with high-dose methotrexate. AJNR Am J Neuroradiol. 2005 May;26(5):1263-9. Review.
Lowe EJ, Pui CH, Hancock ML, Geiger TL, Khan RB, Sandlund JT. Early complications in children with acute lymphoblastic leukemia presenting with hyperleukocytosis. Pediatr Blood Cancer. 2005 Jul;45(1):10-5.
Cheng Q, Yang W, Raimondi SC, Pui CH, Relling MV, Evans WE. Karyotypic abnormalities create discordance of germline genotype and cancer cell phenotypes. Nat Genet. 2005 Aug;37(8):878-82. Epub 2005 Jul 24.
Zaza G, Cheok M, Yang W, Panetta JC, Pui CH, Relling MV, Evans WE. Gene expression and thioguanine nucleotide disposition in acute lymphoblastic leukemia after in vivo mercaptopurine treatment. Blood. 2005 Sep 1;106(5):1778-85. Epub 2005 May 19.
Pui CH, Pei D, Sandlund JT, Campana D, Ribeiro RC, Razzouk BI, Rubnitz JE, Howard SC, Hijiya N, Jeha S, Cheng C, Downing JR, Evans WE, Relling MV, Hudson M. Risk of adverse events after completion of therapy for childhood acute lymphoblastic leukemia. J Clin Oncol. 2005 Nov 1;23(31):7936-41.
Pui CH, Evans WE. Treatment of acute lymphoblastic leukemia. N Engl J Med. 2006 Jan 12;354(2):166-78. Review.
Flotho C, Coustan-Smith E, Pei D, Iwamoto S, Song G, Cheng C, Pui CH, Downing JR, Campana D. Genes contributing to minimal residual disease in childhood acute lymphoblastic leukemia: prognostic significance of CASP8AP2. Blood. 2006 Aug 1;108(3):1050-7. Epub 2006 Apr 20.
Raimondi SC, Zhou Y, Shurtleff SA, Rubnitz JE, Pui CH, Behm FG. Near-triploidy and near-tetraploidy in childhood acute lymphoblastic leukemia: association with B-lineage blast cells carrying the ETV6-RUNX1 fusion, T-lineage immunophenotype, and favorable outcome. Cancer Genet Cytogenet. 2006 Aug;169(1):50-7.
Jeha S, Behm F, Pei D, Sandlund JT, Ribeiro RC, Razzouk BI, Rubnitz JE, Hijiya N, Howard SC, Cheng C, Pui CH. Prognostic significance of CD20 expression in childhood B-cell precursor acute lymphoblastic leukemia. Blood. 2006 Nov 15;108(10):3302-4. Epub 2006 Aug 8.
Hijiya N, Panetta JC, Zhou Y, Kyzer EP, Howard SC, Jeha S, Razzouk BI, Ribeiro RC, Rubnitz JE, Hudson MM, Sandlund JT, Pui CH, Relling MV. Body mass index does not influence pharmacokinetics or outcome of treatment in children with acute lymphoblastic leukemia. Blood. 2006 Dec 15;108(13):3997-4002. Epub 2006 Aug 17.
Madden RM, Pui CH, Hughes WT, Flynn PM, Leung W. Prophylaxis of Pneumocystis carinii pneumonia with atovaquone in children with leukemia. Cancer. 2007 Apr 15;109(8):1654-8.
Relling MV, Yang W, Das S, Cook EH, Rosner GL, Neel M, Howard S, Ribeiro R, Sandlund JT, Pui CH, Kaste SC. Pharmacogenetic risk factors for osteonecrosis of the hip among children with leukemia. J Clin Oncol. 2004 Oct 1;22(19):3930-6.
Reddick WE, Glass JO, Helton KJ, Langston JW, Li CS, Pui CH. A quantitative MR imaging assessment of leukoencephalopathy in children treated for acute lymphoblastic leukemia without irradiation. AJNR Am J Neuroradiol. 2005 Oct;26(9):2371-7.
Coustan-Smith E, Ribeiro RC, Stow P, Zhou Y, Pui CH, Rivera GK, Pedrosa F, Campana D. A simplified flow cytometric assay identifies children with acute lymphoblastic leukemia who have a superior clinical outcome. Blood. 2006 Jul 1;108(1):97-102. Epub 2006 Mar 14.

Responsible Party: Ching-Hon Pui, MD / Principal Investigator, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187005     History of Changes
Other Study ID Numbers: TOTXIV
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: March 30, 2011
Last Verified: June 2008

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

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Prednisone
Pegaspargase
Cyclophosphamide
Methotrexate
Etoposide
Cytarabine
Vincristine
Daunorubicin
Idarubicin
Asparaginase
6-Mercaptopurine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists


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