Actively Recruiting
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Led by Associazione Italiana Ematologia Oncologia Pediatrica · Updated on 2024-04-15
89
Participants Needed
31
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.
CONDITIONS
Official Title
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed acute promyelocytic leukemia confirmed by the presence of the PML/RARα fusion gene
- Age less than 18 years
- Written informed consent from parents or legal guardians
You will not qualify if you...
- Diagnosis of APL without PML/RARα rearrangement
- Significant liver dysfunction (bilirubin >3 mg/dL, ALT/AST >5 times normal)
- Creatinine levels greater than twice the normal value for age
- Significant heart problems or EKG abnormalities (L-FEV <50% or LV-FS <28%)
- Neuropathy
- Concurrent active cancer
- Uncontrolled life-threatening infections
- Pregnant or breastfeeding females
- Prior alternative therapy for APL (if ATRA or ATO were not initially available)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Hôpital Universitaire des Enfants Reine Fabiola (Huderf)
Brussels, Belgium, 1020
Not Yet Recruiting
2
University Hospital Motol
Prague, Czechia, 15006
Not Yet Recruiting
3
Pediatrics and Adolescent Medicine Aarhus University Hospital
Aarhus N, Denmark, 8200
Not Yet Recruiting
4
CHU de Bordeaux - Hôpital des Enfants
Bordeaux, France, 33076
Actively Recruiting
5
Universitätsklinikum Essen (AöR) Zentrum für Kinder-und Jugendmedizin Klinik für Kinderheilkunde III
Essen, Germany, 45147
Not Yet Recruiting
6
Our Lady's Children's Hospital Crumlin
Dublin, Ireland, 12
Not Yet Recruiting
7
Rappaport Children'S Hospital, Rambam Health Care Campus
Haifa, Israel
Not Yet Recruiting
8
Ospedale "Casa Sollievo della Sofferenza" - UO Oncoematologia Pediatrica
San Giovanni Rotondo, Foggia, Italy, 71013
Actively Recruiting
9
AOU Policlinico Dipartimento di Pediatria
Bari, Italy, 70124
Not Yet Recruiting
10
Ospedale Papa Giovanni XXIII - USS Oncoematologia Pediatrica
Bergamo, Italy, 24100
Not Yet Recruiting
11
AOU Policlinico Sant'Orsola-Malpighi - Oncologia ed Ematologia Pediatrica
Bologna, Italy, 40138
Actively Recruiting
12
Ospedale Pediatrico Microcitemico "A.Cau", Az.Ospedaliera Brotzu - SC Oncoematologia Ped. e Patologia della coagulazione
Cagliari, Italy, 09121
Actively Recruiting
13
AOU Policlinico Vittorio Emanuele - UOC Ematologia ed Oncologia Pediatrica con TNO
Catania, Italy, 95123
Actively Recruiting
14
A.O. Universitaria Meyer - DAI Oncoematologia Pediatrica
Florence, Italy, 50139
Not Yet Recruiting
15
IRCCS Istituto Gannina Gaslini - Dipartimento di Oncoematologia
Genova, Italy, 16147
Actively Recruiting
16
Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM) - Ospedale San Gerardo
Monza, Italy, 20900
Actively Recruiting
17
AORN Santobono-Pausilipon
Naples, Italy, 80123
Actively Recruiting
18
Univerità degli Studi della Campania- Luigi Vanvitelli - Sevizio di Oncologia Pediatrica
Naples, Italy, 80138
Actively Recruiting
19
Azienda Ospedaliera di Padova - Oncoematologia Pediatrica
Padova, Italy, 35128
Not Yet Recruiting
20
ARNAS Civico di Cristina e Benfratelli - UOC Oncoematologia Pediatrica
Palermo, Italy, 90127
Not Yet Recruiting
21
Fondazione IRCCS Policlinico San Matteo - Oncoematologia Pediatrica
Pavia, Italy, 27100
Actively Recruiting
22
Ospedale santa Chiara - AOU Pisana, UO Oncoematologia Pediatrica
Pisa, Italy, 56126
Not Yet Recruiting
23
Policlinico Umberto I Università "LA Sapienza" - Dip. Biotecnologie cellulari ed ematologia UOS Ematologia Pediatrica
Roma, Italy, 00161
Not Yet Recruiting
24
Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica - Ospedale Pediatrico "Bambino Gesù"
Roma, Italy, 00165
Actively Recruiting
25
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Torino, Italy, 10126
Actively Recruiting
26
VU medisch centrum
Amsterdam, Netherlands
Not Yet Recruiting
27
Centro Hospitalar Universitário de Coimbra - Hospital Pediátrico de Coimbra
Coimbra, Portugal, 3000-602
Not Yet Recruiting
28
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, Portugal, 1099-023
Not Yet Recruiting
29
Instituto Português de Oncologia do Porto Francisco Gentil, E. P. E.
Porto, Portugal, 4200-072
Not Yet Recruiting
30
Valencia University Medical School University Hospital La Fe
Valencia, Spain, 46026
Not Yet Recruiting
31
Childrens hematology and oncology Uppsala University
Uppsala, Sweden, .O. Box 256, SE-751 05
Not Yet Recruiting
Research Team
A
AIEOP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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