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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/NCT00002812
Registration number
NCT00002812
Ethics application status
Date submitted
1/11/1999
Date registered
24/11/2003
Date last updated
26/08/2013
Titles & IDs
Public title
Combination Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
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Scientific title
Treatment of Patients With Acute Lymphoblastic Leukemia With Unfavorable Features: A Phase III Group-wide Study
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Secondary ID [1]
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CCG-1961
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Secondary ID [2]
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1961
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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 - idarubicin
Treatment: Drugs - mercaptopurine
Treatment: Drugs - methotrexate
Treatment: Drugs - pegaspargase
Treatment: Drugs - prednisone
Treatment: Drugs - thioguanine
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy
Experimental: Arm A - Standard BFM of Standard Duration (RER) - Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow. Consolidation (Phase II) (5 weeks) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
Experimental: Arm B - Standard BFM with Double Delayed Intensification (RER) - Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (5 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
Experimental: Arm C - Augumented BFM of Standard Duration (RER) - Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (9 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
Experimental: Arm D - Augmented BFM with Dbl Delayed Intensification (RER) - Induction chemotherapy Days 0 - 7. Prednisone 60 mg/m² PO 4 x day. Vincristine sulfate 1.5 mg/m² IV push weekly x 2 Days 0 and 7. Daunomycin (daunorubicin hydrochloride) 25 mg/m² IV push (over 15 min.) weekly x 2 Days 0 and 7. IT Cytosine Arabinoside (cytarabine, Ara-C) Day 0. Asparaginase 6000 IU/m² IM x 3 Days 3, 5, and 7. Day 7 Bone Marrow Consolidation (9 weeks) (Phase II) Prednisone Taper, cyclophosphamide, cytosine arabinoside (Ara-C), mercaptopurine, vincristine sulfate, pegaspargase, IT Methotrexate and radiation therapy.
Treatment: Drugs: asparaginase
Given IV
Treatment: Drugs: cyclophosphamide
Given IV
Treatment: Drugs: cytarabine
Given IV
Treatment: Drugs: daunorubicin hydrochloride
Given IV
Treatment: Drugs: dexamethasone
Given IV
Treatment: Drugs: doxorubicin hydrochloride
Given IV
Treatment: Drugs: idarubicin
Given IV
Treatment: Drugs: mercaptopurine
Given IV
Treatment: Drugs: methotrexate
Given PO
Treatment: Drugs: pegaspargase
Given IV
Treatment: Drugs: prednisone
Given PO
Treatment: Drugs: thioguanine
Given IV
Treatment: Drugs: vincristine sulfate
Given IV
Treatment: Other: radiation 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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The primary outcome index used in examining most of the randomized treatment groups will be event-free survival (EFS).
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Timepoint [1]
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from the time of randomization where the life table events will consist of the first occurrence of the following events: failure to achieve remission, leukemic relapse at any site, death, or occurrence of a second malignancy.
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Acute lymphocytic leukemia (ALL) with M3 bone marrow No FAB L3
morphology CNS or overt testicular leukemia at diagnosis allowed High risk status 10-21
years old with any white blood count (WBC) 1-9 years old with WBC of 50,000/mm3 or greater
PATIENT CHARACTERISTICS: Age: 1 to 21 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not
specified
PRIOR CONCURRENT THERAPY: No prior therapy for ALL except: Emergency therapy for blast
crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration Biologic
therapy: Not specified Chemotherapy: Intrathecal cytarabine or methotrexate allowed at
diagnostic lumbar puncture Induction therapy must begin within 72 hours after intrathecal
injection Endocrine therapy: At least 1-2 months since prior prednisone, for less than 48
hours, for reactive airway disease Inhalational steroids allowed Radiotherapy: Not
specified Surgery: Not specified
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Minimum age
1
Year
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Maximum age
21
Years
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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
Open (masking not 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
1/09/1996
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
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Sample size
Target
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Accrual to date
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Final
2078
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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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Illinois
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Indiana
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Iowa
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Nebraska
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North Carolina
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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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Other collaborator category [1]
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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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 the drugs in different
combinations may kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination
chemotherapy treatment with more intensive combination chemotherapy in treating children with
acute lymphocytic leukemia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00002812
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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.
Butturini AM, Dorey FJ, Lange BJ, Henry DW, Gaynon PS, Fu C, Franklin J, Siegel SE, Seibel NL, Rogers PC, Sather H, Trigg M, Bleyer WA, Carroll WL. Obesity and outcome in pediatric acute lymphoblastic leukemia. J Clin Oncol. 2007 May 20;25(15):2063-9. doi: 10.1200/JCO.2006.07.7792.
Avramis VI, Panosyan EH. Pharmacokinetic/pharmacodynamic relationships of asparaginase formulations: the past, the present and recommendations for the future. Clin Pharmacokinet. 2005;44(4):367-93. doi: 10.2165/00003088-200544040-00003.
Seibel NL, Asselin BL, Nachman JB, et al.: Treatment of high risk T-cell acute lymphoblastic leukemia (T-ALL): comparison of recent experience of the Children's Cancer Group (CCG) and Pediatric Oncology Group (POG). [Abstract] Blood 104 (11): A-681, 2004.
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Public notes
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Contacts
Principal investigator
Name
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Nita L. Seibel, MD
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Address
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Children's National Research Institute
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00002812
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