Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00137111
First received: August 25, 2005
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The primary objective is to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy and to monitor the molecular remission induction rate.


Condition Intervention Phase
Lymphoblastic Leukemia, Acute
Drug: Prednisone, Dexamethasone, Vincristine, Daunorubicin
Drug: Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase
Drug: Methotrexate, Cyclophosphamide, Cytarabine, Etoposide
Drug: Mercaptopurine, Imatinib
Procedure: chemotherapy, intrathecal chemotherapy
Procedure: steroid therapy, hematopoietic stem cell transplantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Total XV - Total Therapy Study XV 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:
  • Overall Event-free Survival (EFS) [ Time Frame: Median follow-up time (range) 5.6 (1.3 to 8.9) years ] [ Designated as safety issue: No ]
    EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.

  • Continuous Complete Remission Since Week 56 Therapy. [ Time Frame: Median follow up time (range) 4.5 (1 to 7.8) years ] [ Designated as safety issue: No ]
    CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.


Secondary Outcome Measures:
  • Minimal Residual Disease (MRD) [ Time Frame: End of Induction (Day 46 MRD measurement) ] [ Designated as safety issue: No ]
    Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%).

  • Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours). [ Time Frame: 42 hours after start of high dose methotrexate infusion (HDMTX) ] [ Designated as safety issue: No ]
    Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.

  • Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours) [ Time Frame: Immediately before the methotrexate infusion and three days after subsequent infusion ] [ Designated as safety issue: No ]

    White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count

    Measurement: Percentage change of leukemia cells from baseline



Enrollment: 501
Study Start Date: June 2000
Estimated Study Completion Date: November 2020
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Prednisone, Dexamethasone, Vincristine, Daunorubicin
See Detailed Description sections for details on treatment interventions.
Drug: Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase
See Detailed Description sections for details on treatment interventions.
Drug: Methotrexate, Cyclophosphamide, Cytarabine, Etoposide
See Detailed Description sections for details on treatment interventions.
Drug: Mercaptopurine, Imatinib
See Detailed Description sections for details on treatment interventions.
Procedure: chemotherapy, intrathecal chemotherapy
See Detailed Description sections for details on treatment interventions.
Procedure: steroid therapy, hematopoietic stem cell transplantation
See Detailed Description sections for details on treatment interventions.
2 Drug: Prednisone, Dexamethasone, Vincristine, Daunorubicin
See Detailed Description sections for details on treatment interventions.
Drug: Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase
See Detailed Description sections for details on treatment interventions.
Drug: Methotrexate, Cyclophosphamide, Cytarabine, Etoposide
See Detailed Description sections for details on treatment interventions.
Drug: Mercaptopurine, Imatinib
See Detailed Description sections for details on treatment interventions.
Procedure: chemotherapy, intrathecal chemotherapy
See Detailed Description sections for details on treatment interventions.
Procedure: steroid therapy, hematopoietic stem cell transplantation
See Detailed Description sections for details on treatment interventions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of non-B-cell ALL by immunophenotyping, as determined by the reactivity pattern to a panel of monoclonal antibodies with flow cytometry as well as morphology and cytochemical staining.
  • Age range: 1 to 18 years (inclusive).

Exclusion Criteria:

• Previously treated with chemotherapy for one week or longer.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137111

Locations
United States, Tennessee
St Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Ching-Hon Pui, M.D. St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00137111     History of Changes
Other Study ID Numbers: TOTXV, R37CA036401, P30CA021765
Study First Received: August 25, 2005
Results First Received: February 28, 2011
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Pegaspargase
Imatinib
Asparaginase
Daunorubicin
Dexamethasone
Doxorubicin
Etoposide
Prednisone
Vincristine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014