Treatment Study for Children and Adolescents With Acute Promyelocitic Leukemia
NCT01226303 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2017-01-26
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, NuMA-RARalpha) and less than 21 years of age (for AIEOP, see appendix A).
Conditions
- Acute Promyelocytic Leukemia
Interventions
- DRUG
-
ATRA
see the protocol
- DRUG
-
ATRA + IDA
see the protocol
Sponsors & Collaborators
-
Associazione Italiana Ematologia Oncologia Pediatrica
lead OTHER
Principal Investigators
-
Annamaria Testi, Dr · Associazione Italiana Ematologia Oncologia Pediatrica
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2017-06-30
- Completion
- 2018-12-31
Countries
- Italy
Study Locations
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