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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00002744
Registration number
NCT00002744
Ethics application status
Date submitted
1/11/1999
Date registered
1/09/2004
Date last updated
9/02/2017
Titles & IDs
Public title
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
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Scientific title
Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia
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Secondary ID [1]
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CCG-1952
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Secondary ID [2]
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1952
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - asparaginase
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - cytarabine
Treatment: Drugs - daunorubicin hydrochloride
Treatment: Drugs - dexamethasone
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - mercaptopurine
Treatment: Drugs - methotrexate
Treatment: Drugs - pegaspargase
Treatment: Drugs - prednisone
Treatment: Drugs - therapeutic hydrocortisone
Treatment: Drugs - thioguanine
Treatment: Drugs - vincristine sulfate
Treatment: Other - low-LET cobalt-60 gamma ray therapy
Treatment: Other - low-LET photon therapy
Experimental: Arm I - Therapy defined in description.
Experimental: Arm 2 - Therapy defined in description.
Experimental: Arm 3 - Therapy defined in description.
Experimental: Arm 4 - Therapy defined in description.
Treatment: Drugs: asparaginase
Treatment: Drugs: cyclophosphamide
Treatment: Drugs: cytarabine
Treatment: Drugs: daunorubicin hydrochloride
Treatment: Drugs: dexamethasone
Treatment: Drugs: doxorubicin hydrochloride
Treatment: Drugs: mercaptopurine
Treatment: Drugs: methotrexate
Treatment: Drugs: pegaspargase
Treatment: Drugs: prednisone
Treatment: Drugs: therapeutic hydrocortisone
Treatment: Drugs: thioguanine
Treatment: Drugs: vincristine sulfate
Treatment: Other: low-LET cobalt-60 gamma ray therapy
Treatment: Other: low-LET photon therapy
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event Free Survival
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Assessment method [1]
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Primary outcome index used in examining the randomized treatment groups will be event-free survival (EFS) from the time of randomization (i.e., end of Induction), where the life table events will consist of the first occurrence of leukemic relapse at any site, death, or occurrence of a second malignancy.
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Timepoint [1]
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Secondary outcome [1]
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Comparisons of CNS relapse incidence rates
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Assessment method [1]
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Comparisons of CNS relapse incidence rates for the IT MTX versus ITT groups is also planned as an important endpoint.
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Timepoint [1]
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Newly diagnosed acute lymphoblastic leukemia (ALL) obtained by
bone marrow aspirate or bone marrow biopsy No greater than 25% L3 blasts Initial white
blood cell count less than 50,000/mm3 (performed at CCG institution) Massive
lymphadenopathy, massive splenomegaly, and/or large mediastinal mass allowed CNS or
testicular leukemia allowed Allogeneic bone marrow transplant should be considered (if
donor available) for patients with Philadelphia chromosome (t[9;22][q34;q11]) or
translocation (4;11)(q21;q23)
PATIENT CHARACTERISTICS: Age: 1 through 9 Performance status: Not specified Hematopoietic:
See Disease Characteristics Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: No prior treatment for ALL Biologic therapy: Not specified
Chemotherapy: Intrathecal cytarabine (IT ARA-C) may begin prior to registration provided
systemic chemotherapy initiated within 72 hours after IT ARA-C Endocrine therapy: See
Radiotherapy At least 1 month since prior systemic steroids Steroids given for less than 48
hours allowed Inhaled corticosteroids allowed at any time Radiotherapy: Radiotherapy or
dexamethasone for mediastinal mass causing superior mediastinal syndrome allowed prior to
registration, if indicated Surgery: Not specified
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Minimum age
1
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Maximum age
9
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/1996
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2007
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Sample size
Target
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Accrual to date
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Final
1970
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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6001 - Perth
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Recruitment outside Australia
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United States of America
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California
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Colorado
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North Carolina
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Utah
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Wisconsin
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Canada
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British Columbia
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Canada
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Nova Scotia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug and giving them in different ways
may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is
more effective for acute lymphoblastic leukemia
PURPOSE: Randomized phase III trial to compare different regimens of combination chemotherapy
in treating children who have newly diagnosed acute lymphoblastic leukemia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00002744
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Trial related presentations / publications
Nguyen K, Devidas M, Cheng SC, La M, Raetz EA, Carroll WL, Winick NJ, Hunger SP, Gaynon PS, Loh ML; Children's Oncology Group. Factors influencing survival after relapse from acute lymphoblastic leukemia: a Children's Oncology Group study. Leukemia. 2008 Dec;22(12):2142-50. doi: 10.1038/leu.2008.251. Epub 2008 Sep 25.
Matloub Y, Asselin BL, Stork LC, et al.: Outcome of children with T-Cell acute lymphoblastic leukemia (T-ALL) and standard risk (SR) features: results of CCG-1952, CCG-1991 and POG 9404. [Abstract] Blood 104 (11): A-680, 195a, 2004.
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Public notes
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Contacts
Principal investigator
Name
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Linda C. Stork, MD
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Address
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Doernbecher Children's Hospital at Oregon Health and Science University
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00002744
Download to PDF