Status:
UNKNOWN
Treatment Study for Children and Adolescents With Acute Promyelocitic Leukemia
Lead Sponsor:
Associazione Italiana Ematologia Oncologia Pediatrica
Conditions:
Acute Promyelocytic Leukemia
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
Brief Summary
This study is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR positive for the PML-RARα transcript or rarer retinoid sensitive subtypes (i.e. NPM-RAR-alpha, NuM...
Detailed Description
This study is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR positive for the PML-RARα transcript or rarer retinoid sensitive subtypes (i.e. NPM-RARalpha, NuMA...
Eligibility Criteria
Inclusion
- Patients with a clinical diagnosis of initial APL and subsequently confirmed to have PML-RARα, NPM1-RARα or NUMA-RARα 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
- Patients with a clinical diagnosis of APL but subsequently found to have PLZF-RARα fusion or lacking PML-RARα, NPM-RARα or NuMA-RARα rearrangement should be withdrawn from the study and treated on an alternative protocol.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).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01226303
Start Date
January 1 2009
End Date
December 1 2018
Last Update
January 26 2017
Active Locations (1)
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1
Dipartimento di Biotecnologie Cellulari ed Ematologia
Roma, Italy, 00161