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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/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
Other interventions - filgrastim
Treatment: Drugs - asparaginase
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - cytarabine
Treatment: Drugs - daunorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - leucovorin calcium
Treatment: Drugs - mercaptopurine
Treatment: Drugs - methotrexate
Treatment: Drugs - prednisone
Treatment: Drugs - therapeutic hydrocortisone
Treatment: Drugs - vincristine sulfate

Experimental: Chemo (Reduced Induction) No BMT (Open February 2004) -


Other interventions: filgrastim


Treatment: Drugs: asparaginase


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: cytarabine


Treatment: Drugs: daunorubicin hydrochloride


Treatment: Drugs: etoposide


Treatment: Drugs: leucovorin calcium


Treatment: Drugs: mercaptopurine


Treatment: Drugs: methotrexate


Treatment: Drugs: prednisone


Treatment: Drugs: therapeutic hydrocortisone


Treatment: Drugs: vincristine sulfate
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
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
N/A
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
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United States of America
State/province [1] 0 0
Alabama
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Arizona
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Arkansas
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California
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Connecticut
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United States of America
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District of Columbia
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Florida
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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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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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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
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from
dividing so they stop growing or die. Combining more than one chemotherapy drug and giving
them as induction intensification may kill more cancer cells.

PURPOSE: This phase II trial is studying how well induction intensification works in treating
infants with newly diagnosed acute lymphocytic leukemia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002756
Trial related presentations / publications
Dreyer ZE, Dinndorf PA, Camitta B, Sather H, La MK, Devidas M, Hilden JM, Heerema NA, Sanders JE, McGlennen R, Willman CL, Carroll AJ, Behm F, Smith FO, Woods WG, Godder K, Reaman GH. Analysis of the role of hematopoietic stem-cell transplantation in infants with acute lymphoblastic leukemia in first remission and MLL gene rearrangements: a report from the Children's Oncology Group. J Clin Oncol. 2011 Jan 10;29(2):214-22. doi: 10.1200/JCO.2009.26.8938. Epub 2010 Dec 6.
Fernandez CV, Kodish E, Taweel S, Shurin S, Weijer C; Children's Oncology Group. Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group. Cancer. 2003 Jun 1;97(11):2904-9. doi: 10.1002/cncr.11391.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00002756