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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01226303 |
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Date of registration:
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20/10/2010 |
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Primary sponsor: |
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Public title:
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Treatment Study for Children and Adolescents With Acute Promyelocitic Leukemia
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Scientific title:
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Treatment Study for Children and Adolescents With Acute Promyelocitic Leukemia |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01226303 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Testi, Dr |
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Address:
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Telephone:
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06.857951 |
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Email:
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testi@bce.uniroma1.it |
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Affiliation:
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Name:
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Annamaria Testi, PI |
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Address:
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Telephone:
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06.857951 |
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Email:
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testi@bce.uniroma1.it |
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Affiliation:
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Name:
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Annamaria Testi, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Associazione Italiana Ematologia Oncologia Pediatrica |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a clinical diagnosis of initial APL and subsequently confirmed to have
PML-RARa, NPM1-RARa or NUMA-RARa fusion. Whilst this study is only for ATRA-sensitive
APL, APL is a hematological emergency and ATRA should be commenced as soon as the
diagnosis is suspected. Study entry should not wait until the diagnosis of APL has
been confirmed molecularly or cytogenetically
- Less than 21 years of age at initial diagnosis (for AIEOP, see appendix A)
- Considered suitable for anthracycline-based chemotherapy
- Written informed consent available
- Females of childbearing age must have a negative pregnancy test and subsequently must
attempt to avoid pregnancy
Exclusion Criteria:
- Patients with a clinical diagnosis of APL but subsequently found to have PLZF-RARa
fusion or lacking PML-RARa, NPM-RARa or NuMA-RARa rearrangement should be withdrawn
from the study and treated on an alternative protocol.
- Refractory/relapsed APL (the guidelines in this protocol for that subgroup are
intended for patients treated from initial diagnosis according to this protocol)
- Concurrent active malignancy
- Pregnant or lactating
- Physician and patient/guardian think that intensive chemotherapy is not an
appropriate treatment option
- Patients who have received alternative chemotherapy for 7 days or longer without ATRA
for any reason (either APL not initially suspected or ATRA not available).
Age minimum:
N/A
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Promyelocytic Leukemia
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Intervention(s)
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Drug: ATRA
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Primary Outcome(s)
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• to conduct an international pediatric study for APL based on the GIMEMA-AIEOP/AIDA 93 protocol (the study from the Italian GIMEMA -AIEOP group which has produced the best results in children with APL to date), with optimal outcome and less toxicity
[Time Frame: • to conduct an international pediatric study for APL based on the GIMEMA-AIEOP/AIDA 93 protocol (the study from the Italian GIMEMA -AIEOP group which has produced the best results in children with APL to date), with optimal outcome and less toxicity]
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Secondary Outcome(s)
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• To monitor cardiotoxicity by echocardiography
[Time Frame: • To monitor cardiotoxicity by echocardiography]
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Secondary ID(s)
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ICC APL STUDY 01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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