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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00002744




Registration number
NCT00002744
Ethics application status
Date submitted
1/11/1999
Date registered
1/09/2004
Date last updated
10/02/2017

Titles & IDs
Public title
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
Scientific title
Randomized Comparisons of Oral Mercaptopurine vs Oral Thioguanine and IT Methotrexate vs ITT for Standard Risk Acute Lymphoblastic Leukemia
Secondary ID [1] 0 0
CCG-1952
Secondary ID [2] 0 0
1952
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
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
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


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

Outcomes
Primary outcome [1] 0 0
Event Free Survival - 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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Comparisons of CNS relapse incidence rates - Comparisons of CNS relapse incidence rates for the IT MTX versus ITT groups is also planned as an important endpoint.
Timepoint [1] 0 0

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
Minimum age
1 Year
Maximum age
9 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
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 York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 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 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.
Trial website
https://clinicaltrials.gov/show/NCT00002744
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.
Public notes

Contacts
Principal investigator
Name 0 0
Linda C. Stork, MD
Address 0 0
Doernbecher Children's Hospital at Oregon Health and Science University
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

Summary results
Other publications