Vyxeos Liposomal 44 mg/100 mg powder for concentrate for solution for infusion.

DRUG7 trials

Sponsors

Centre Hospitalier Universitaire De Nice, GPOH gGmbH, University of Leipzig, Universitaetsklinikum Ulm AöR, Prinses Maxima Centrum voor Kinderoncologie B.V.

Conditions

AMLAcute Myeloid LeukemiaAcute myeloid leukemiaHigh-risk Myelodysplastic neoplasiaMyeloid Leukemia in Children with Down SyndromePatients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria)Untreated patients with higher risk MDS and oligoblastic AML eligible and intended for allogeneic HCT within the next 6 monthsincluding AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification

Phase 1

A Phase Ib study of Vyxeos® (liposomal daunorubicin and cytarabine) in combination with Clofarabine in children with relapsed/refractory AML

RecruitingCTIS2023-508050-26-00

Prinses Maxima Centrum voor Kinderoncologie B.V.AML

Start: 2025-07-17Target: 25Updated: 2025-10-21

Phase 2

An ALFA 2101 multicenter randomized phase II study: CPX-351 versus intensive chemotherapy in patients with de novo intermediate or adverse risk AML stratified by genomics

RecruitingCTIS2022-500295-60-00

Centre Hospitalier Universitaire De NiceAcute Myeloid Leukemia

Start: 2022-09-15Target: 210Updated: 2025-05-13

Magrolimab plus intensive chemotherapy in newly diagnosed “ELN intermediate or poor-risk” AML patients intended to undergo allogeneic stem cell transplantation, a Phase 2, Single-arm, Open-Label Study (MAGROLIC)

CompletedCTIS2022-502040-13-00

University of LeipzigAcute myeloid leukemia, High-risk Myelodysplastic neoplasia

End: 2024-02-08Target: 108Updated: 2023-07-18

Primary comparison of Liposomal Anthracycline based treatment versus conventional care strategies prior to allogeneic stem cell transplantation in patients with higher risk MDS or oligoblastic AML

Active, not recruitingCTIS2024-515375-35-00

GWT-Tud GmbHUntreated patients with higher risk MDS and oligoblastic AML eligible and intended for allogeneic HCT within the next 6 months

Start: 2019-08-26Target: 150Updated: 2025-11-05

Phase 3

International multicenter, open-label clinical trial for the treatment of acute myeloid leukemia in children and adolescents

RecruitingCTIS2022-500783-35-00

GPOH gGmbHAcute Myeloid Leukemia

Start: 2022-12-06Target: 1091Updated: 2025-09-25

Phase III Clinical Trial for CPX-351 in Myeloid Leukemia in Children with Down Syndrome 2018

Active, not recruitingCTIS2022-501457-37-00

GPOH gGmbHMyeloid Leukemia in Children with Down Syndrome

Start: 2024-10-28Target: 220Updated: 2025-10-29

Randomized Phase III Study of Standard Intensive Chemotherapy versus Intensive Chemotherapy with CPX-351 in Adult Patients with Newly Diagnosed AML and Intermediate- or Adverse Genetics

Active, not recruitingCTIS2023-503670-21-00

Universitaetsklinikum Ulm AöRincluding AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification, Patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria)

Start: 2019-08-28Target: 842Updated: 2025-11-20