Actively Recruiting

Phase 2
Age: 0 - 18Years
All Genders
NCT04793919

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

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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