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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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COG-AAML00P2
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Secondary ID [2]
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AAML00P2
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia
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Myelodysplastic Syndromes
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Blood
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Haematological diseases
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Blood
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Other blood disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event Free Survival
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Length of study
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Secondary outcome [1]
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Toxicity
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Toxicity will be monitored through study chair notification and end course reports
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Timepoint [1]
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Secondary outcome [2]
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Remission Rate
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Assessment method [2]
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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.
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Timepoint [2]
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Length of study
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Secondary outcome [3]
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Prognostic Factor Analysis
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Assessment method [3]
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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
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Timepoint [3]
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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
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Minimum age
No limit
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Maximum age
21
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Intervention assignment
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Phase
Phase 1
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2002
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2012
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Sample size
Target
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Accrual to date
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Final
47
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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6001 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00028899
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Trial related presentations / publications
Aplenc R, Alonzo TA, Gerbing RB, Lange BJ, Hurwitz CA, Wells RJ, Bernstein I, Buckley P, Krimmel K, Smith FO, Sievers EL, Arceci RJ; Children's Oncology Group. Safety and efficacy of gemtuzumab ozogamicin in combination with chemotherapy for pediatric acute myeloid leukemia: a report from the Children's Oncology Group. J Clin Oncol. 2008 May 10;26(14):2390-3295. doi: 10.1200/JCO.2007.13.0096.
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Public notes
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Contacts
Principal investigator
Name
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Richard Aplenc, MD, MSCE
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Address
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Children's Hospital of Philadelphia
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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
Type
Citations or Other Details
Journal
Aplenc R, Alonzo TA, Gerbing RB, Lange BJ, Hurwitz...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00028899
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