Vyxeos® With Clofarabine for Pediatric AML

PHASE1RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

November 6, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Relapsed Pediatric AMLRefractory Pediatric AML
Interventions
DRUG

Vyxeos 44 MG / 100 MG Liposome Injection

Vyxeos®/CPX-351 will be infused in 90 minutes on day 1, 3 and 5 only, 3 hours after the end of clofarabine (if administered on the same day).

DRUG

Clofarabine

Clofarabine infusion will be given according to the assigned dose level, over 2 hours IV, daily on day 2-6 (for 5 consecutive days).

Trial Locations (13)

Unknown

RECRUITING

St. Anna Kinderspital, Vienna

RECRUITING

Rigshospitalet, Copenhagen

RECRUITING

Universitätsklinikum Augsburg, Augsburg

RECRUITING

Charité Berlin, Berlin

RECRUITING

University Children´s Hospital III Essen, Essen

RECRUITING

Universitätsklinikum Frankfurt, Frankfurt

RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Hamburg

RECRUITING

Clinica Pediatrica Fondazione MBBM, Monza

RECRUITING

Ospedale Pediatrico Bambino Gesu (OPBG), Roma

RECRUITING

Hospital Sant Joan de Déu, Barcelona

RECRUITING

Hospital Vall D'Hebron, Barcelona

RECRUITING

Hospital Infantil Universitario Niño Jesús, Madrid

3584 CS

RECRUITING

Princess Maxima Center, Utrecht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

Princess Maxima Center for Pediatric Oncology

OTHER