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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00028899




Registration number
NCT00028899
Ethics application status
Date submitted
4/01/2002
Date registered
27/01/2003
Date last updated
20/02/2014

Titles & IDs
Public title
Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
Scientific title
A Dose Finding Study of the Safety of Gemtuzumab Ozogamicin Combined With Conventional Chemotherapy for Patients With Relapsed or Refractory Acute Myeloid Leukemia
Secondary ID [1] 0 0
COG-AAML00P2
Secondary ID [2] 0 0
AAML00P2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Myelodysplastic Syndromes 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
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - asparaginase
Treatment: Drugs - cytarabine
Treatment: Drugs - gemtuzumab ozogamicin
Treatment: Drugs - mitoxantrone hydrochloride

Treatment: Drugs: asparaginase


Treatment: Drugs: cytarabine


Treatment: Drugs: gemtuzumab ozogamicin


Treatment: Drugs: mitoxantrone hydrochloride


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

Outcomes
Primary outcome [1] 0 0
Event Free Survival
Timepoint [1] 0 0
Length of study
Secondary outcome [1] 0 0
Toxicity - Toxicity will be monitored through study chair notification and end course reports
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Remission Rate - The remission rate in each arm will be estimated by the proportion of patients who achieved remission among patients who received GMTZ at the MTD level.
Timepoint [2] 0 0
Length of study
Secondary outcome [3] 0 0
Prognostic Factor Analysis - The predictive value of the likelihood of leukemia blast cells to undergo apoptosis and drug resistance of leukemia blast cells will be assessed by logistic regression
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Diagnosis of primary acute myeloid leukemia (AML) or myelodysplastic syndromes

- Relapsed (remission duration less than 1 year) OR

- Failed induction (failed to achieve an initial complete response)

- Patients with AML as a second malignant neoplasm allowed provided no other prior
therapy for AML

- M2 or M3 bone marrow aspirate at time of study entry

- No Fanconi's anemia

- No known CNS leukemia

PATIENT CHARACTERISTICS:

Age:

- 21 and under

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 1.5 times normal

- AST or ALT less than 2.5 times upper limit of normal

- No history of veno-occlusive disease of the liver defined as weight increase of more
than 5% over baseline and serum bilirubin greater than 5 mg/dL within 20 days after
receipt of chemotherapy

Renal:

- Creatinine no greater than 1.5 times normal OR

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70
mL/min OR

- Equivalent GFR by institutional normal range

Cardiovascular:

- Shortening fraction more than 27% by echocardiogram or normal for institution OR

- Ejection fraction more than 50% by MUGA

Other:

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 180 days since prior hematopoietic stem cell transplantation

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified
Minimum age
No limit
Maximum age
21 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
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
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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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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Illinois
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Indiana
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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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New Jersey
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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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Pennsylvania
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South Carolina
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Tennessee
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Texas
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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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Ontario
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Canada
State/province [34] 0 0
Quebec

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. Monoclonal antibodies such as gemtuzumab ozogamicin can
locate cancer cells and either kill them or deliver cancer-killing substances to them without
harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may
kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with
combination chemotherapy in treating children who have relapsed or refractory acute myeloid
leukemia or myelodysplastic syndrome.
Trial website
https://clinicaltrials.gov/show/NCT00028899
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Aplenc, MD, MSCE
Address 0 0
Children's Hospital of Philadelphia
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