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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00070174




Registration number
NCT00070174
Ethics application status
Date submitted
3/10/2003
Date registered
7/10/2003
Date last updated
20/02/2014

Titles & IDs
Public title
Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy
Scientific title
Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study
Secondary ID [1] 0 0
CDR0000330133
Secondary ID [2] 0 0
AAML03P1
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
Primary outcome [2] 0 0
Complete remission rate
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Feasibility
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Effect of karyotypic abnormalities
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Newly diagnosed primary acute myeloid leukemia (AML)

* At least 20% bone marrow blasts
* Meets the customary FAB criteria for AML

* Patients with cytopenias and bone marrow blasts who do not meet the FAB criteria are eligible provided they have a karyotypic abnormality characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they have the unequivocal presence of megakaryoblasts
* Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results outlined above
* Previously untreated disease
* No promyelocytic leukemia (FAB M3)
* No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed sideroblasts)
* No juvenile myelomonocytic leukemia
* No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
* No Down syndrome

PATIENT CHARACTERISTICS:

Age

* 1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease are allowed

Performance status

* Karnofsky 50-100% (over 16 years of age) OR
* Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a performance status

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* No inadequate liver function

Renal

* No inadequate renal function
* No hyperuricemia (greater than 8.0 mg/dL)
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR an equivalent normal GFR OR
* Creatinine no greater than 1.5 times normal

Cardiovascular

* Shortening fraction at least 27% by echocardiogram OR
* Ejection fraction at least 50% by MUGA

Pulmonary

* No proven or suspected pneumonia

Other

* Not pregnant or nursing
* No proven or suspected sepsis or meningitis

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy except intrathecal cytarabine administered that was administered at diagnosis

Endocrine therapy

* Prior topical and inhalation steroids allowed
* No concurrent steroids as antiemetics

Radiotherapy

* No prior radiotherapy

Surgery

* Not specified

Other

* No prior antileukemic therapy
* No concurrent pressor agent or ventilatory support unless approved by the study chair
* No concurrent participation in another COG therapeutic study
Minimum age
No limit
Maximum age
No limit
Sex
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
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
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Office of S. David Lang - Herston, Brisbane
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston, Brisbane
Recruitment postcode(s) [3] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
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California
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United States of America
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Colorado
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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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Delaware
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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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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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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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Nebraska
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Nevada
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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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North Dakota
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Ohio
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United States of America
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Oklahoma
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Oregon
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Pennsylvania
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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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United States of America
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Vermont
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United States of America
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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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Newfoundland and Labrador
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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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Puerto Rico
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Santurce
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Switzerland
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Chihuahua

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
Janet Franklin, MD, MPH
Address 0 0
Children's Hospital Los Angeles
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/NCT00070174