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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00002756




Registration number
NCT00002756
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
14/02/2014

Titles & IDs
Public title
Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia
Scientific title
Induction Intensification in Infant ALL: A Children's Oncology Group Study
Secondary ID [1] 0 0
COG-P9407
Secondary ID [2] 0 0
P9407
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Chemo (Reduced Induction) No BMT (Open February 2004) -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of intensification
Timepoint [1] 0 0
Primary outcome [2] 0 0
Event-free survival
Timepoint [2] 0 0
Primary outcome [3] 0 0
Comparison of event-free survival rates in infants with and without leukemic blasts translocations
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Correlation of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Clinical prognostic features associated with outcome
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Correlation of biologic characteristics of leukemia cells at diagnosis with outcome
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Patterns of gene expression
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia

* No infants less than 36 weeks' gestation
* CNS or testicular disease permitted
* No B-cell ALL or acute myeloid leukemia
* Previously untreated except for the following:

* Steroid treatment within 48 hours of diagnosis allowed with physical examination and differential CBC immediately prior to beginning steroids
* Concurrent registration on protocol POG-9900 (ALL classification study) required
* Patients registered on POG-9407 are eligible for the pharmacokinetic part of the study

PATIENT CHARACTERISTICS:

Age:

* Under 1 at diagnosis

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No uncontrolled infection
* Adequate major organ function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* See Disease Characteristics
* No concurrent chronic steroid treatment

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No other concurrent anticancer therapy
Minimum age
No limit
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
1/06/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
221
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
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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United States of America
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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United States of America
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Switzerland
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Bern
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Switzerland
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Geneva
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Switzerland
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Lausanne

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zoann E. Dreyer, MD
Address 0 0
Texas Children's Cancer Center
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00002756