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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/NCT00002590
Registration number
NCT00002590
Ethics application status
Date submitted
1/11/1999
Date registered
29/04/2004
Date last updated
24/07/2014
Titles & IDs
Public title
Combination Chemotherapy in Treating Children With Lymphoma
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Scientific title
A Pilot Study For The Treatment of Newly-Diagnosed Disseminated Anaplastic Large Cell Ki-1 Lymphoma and T-Large Cell Lymphoma
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Secondary ID [1]
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CCG-5941
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Secondary ID [2]
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5941
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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:
Lymphoma
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Condition category
Condition code
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
Other interventions - filgrastim
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - cytarabine
Treatment: Drugs - daunorubicin hydrochloride
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - leucovorin calcium
Treatment: Drugs - methotrexate
Treatment: Drugs - pegaspargase
Treatment: Drugs - prednisone
Treatment: Drugs - thioguanine
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy
Experimental: Regimen A - See detailed description.
Other interventions: filgrastim
Treatment: Drugs: cyclophosphamide
Treatment: Drugs: cytarabine
Treatment: Drugs: daunorubicin hydrochloride
Treatment: Drugs: doxorubicin hydrochloride
Treatment: Drugs: etoposide
Treatment: Drugs: leucovorin calcium
Treatment: Drugs: methotrexate
Treatment: Drugs: pegaspargase
Treatment: Drugs: prednisone
Treatment: Drugs: thioguanine
Treatment: Drugs: vincristine sulfate
Treatment: Other: radiation therapy
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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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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Estimate toxicity and feasibility of 11 month multiagent chemotx
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Assessment method [1]
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Estimate the toxicity and feasibility of a short (11 month) aggressive multiagent chemotherapy regimen - Intensive NYI\NHL
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Timepoint [1]
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Secondary outcome [1]
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Provide preliminary data for a future phase III study
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Investigate the biology of lymphoblastic lymphoma
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Assessment method [2]
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To continue to investigate the biology of lymphoblastic lymphoma and its relationship to leukemia through the study of immunophenotyping, cytogenetics and molecular analysis.
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Timepoint [2]
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Secondary outcome [3]
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Obtain preliminary data on treatment of anaplastic large cell
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Assessment method [3]
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To obtain preliminary data on treatment of anaplastic large cell (Ki-1) and T-cell large cell lymphoma treated with intensive NYI.
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Timepoint [3]
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Histologically confirmed and previously untreated anaplastic large
cell Ki-1 lymphoma and T-cell large cell lymphoma Malignant lymphoblasts (identified by
immunophenotype) in pleural fluid, ascitic fluid, or bone marrow sufficient for diagnosis
Large cell lymphoma with T-cell phenotype eligible Localized mediastinal disease and bone
lymphoma eligible CNS disease eligible and defined as: Any clearly identifiable tumor cells
in cerebral spinal fluid Cranial nerve palsy (if not explained by extra cranial tumor)
Clinical Spinal Cord Compression Isolated intra cerebral mass No cranial nerve palsies
requiring immediate CNS irradiation
PATIENT CHARACTERISTICS: Age: Under 21 Performance status: Not specified Hematopoietic: Not
specified Hepatic: Not specified Renal: Not specified Cardiovascular: Shortening fraction
greater than 27% on echocardiogram (ECHO) OR Left ventricular ejection fraction greater
than 47% on radionuclide scan (RCNA) OR Cardiac function assessed as within normal limits
by cardiologist ECHO or RCNA obtained as close as clinically possible to start of therapy
PRIOR CONCURRENT THERAPY: No prior therapy except emergency treatment of airway obstruction
or superior vena cava syndrome No more than 72 hours between emergency radiotherapy or
steroids and initiation of protocol therapy
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Minimum age
No limit
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Maximum age
20
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
N/A
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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 2
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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
1/07/1994
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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
221
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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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District of Columbia
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Illinois
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Indiana
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Iowa
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Washington
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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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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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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 tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
children who have lymphoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00002590
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Trial related presentations / publications
Lones MA, Perkins SL, Sposto R, Tedeschi N, Kadin ME, Kjeldsberg CR, Wilson JF, Zwick DL, Cairo MS. Non-Hodgkin's lymphoma arising in bone in children and adolescents is associated with an excellent outcome: a Children's Cancer Group report. J Clin Oncol. 2002 May 1;20(9):2293-301. doi: 10.1200/JCO.2002.06.017.
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Public notes
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Contacts
Principal investigator
Name
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Minnie Abromowitch, MD
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Address
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Children's Hospital Medical Center, Cincinnati
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00002590
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