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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00002590




Trial ID
NCT00002590
Ethics application status
Date submitted
1/11/1999
Date registered
28/04/2004
Date last updated
23/07/2014

Titles & IDs
Public title
Combination Chemotherapy in Treating Children With Lymphoma
Scientific title
A Pilot Study For The Treatment of Newly-Diagnosed Disseminated Anaplastic Large Cell Ki-1 Lymphoma and T-Large Cell Lymphoma
Secondary ID [1] 0 0
CCG-5941
Secondary ID [2] 0 0
5941
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimate toxicity and feasibility of 11 month multiagent chemotx - Estimate the toxicity and feasibility of a short (11 month) aggressive multiagent chemotherapy regimen - Intensive NYI\NHL
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Provide preliminary data for a future phase III study
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Investigate the biology of lymphoblastic lymphoma - To continue to investigate the biology of lymphoblastic lymphoma and its relationship to leukemia through the study of immunophenotyping, cytogenetics and molecular analysis.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Obtain preliminary data on treatment of anaplastic large cell - To obtain preliminary data on treatment of anaplastic large cell (Ki-1) and T-cell large cell lymphoma treated with intensive NYI.
Timepoint [3] 0 0

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
Minimum age
No limit
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Nova Scotia

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00002590
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.
Public notes

Contacts
Principal investigator
Name 0 0
Minnie Abromowitch, MD
Address 0 0
Children's Hospital Medical Center, Cincinnati
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries