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)

Conditions

High-risk Myelodysplastic neoplasia, Acute myeloid leukemia

Brief summary

The primary endpoint is CR/CRi/CRh at the end of induction therapy of a maximum of two induction cycles.

Detailed description

Overall Survival, OS, i.e. time from study inclusion until death from any cause, Event Free Survival, EFS, i.e. time from study inclusion until non-achievement of a complete remission at the end of induction (after up to two induction chemotherapies), hematological relapse or death from any cause (whichever comes first), Relapse Free Survival, RFS, i.e. the time from achievement of complete remission until hematological relapse, or death from any cause (whichever comes first), only for patients achieving CR, Rate of allogeneic hematopoietic stem cell transplantation, Quality of life, QoL Impact of treatment assessed by using the validated questionnaires EORTC QLQ-C30 and EQ-5D-5L, All AEs and SAEs during induction cycle 1, and possibly induction cycle 2, and consolidation cycles will be collected, CTC-graded, and MEDRA coded. Incidence proportions will be calculated.

Related papers

No related papers found yet.

Interventions

DRUGMagrolimab

DRUGCytarabin Accord 100 mg/ml Injektions-/Infusionslösung

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

DRUGDaunoblastin® 20 mg Pulver zur Herstellung einer Infusions- oder Injektionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is CR/CRi/CRh at the end of induction therapy of a maximum of two induction cycles.	—

Secondary

Measure	Time frame
Overall Survival, OS, i.e. time from study inclusion until death from any cause, Event Free Survival, EFS, i.e. time from study inclusion until non-achievement of a complete remission at the end of induction (after up to two induction chemotherapies), hematological relapse or death from any cause (whichever comes first), Relapse Free Survival, RFS, i.e. the time from achievement of complete remission until hematological relapse, or death from any cause (whichever comes first), only for patients achieving CR, Rate of allogeneic hematopoietic stem cell transplantation, Quality of life, QoL Impact of treatment assessed by using the validated questionnaires EORTC QLQ-C30 and EQ-5D-5L, All AEs and SAEs during induction cycle 1, and possibly induction cycle 2, and consolidation cycles will be collected, CTC-graded, and MEDRA coded. Incidence proportions will be calculated.	—

Measure

Time frame

Overall Survival, OS, i.e. time from study inclusion until death from any cause, Event Free Survival, EFS, i.e. time from study inclusion until non-achievement of a complete remission at the end of induction (after up to two induction chemotherapies), hematological relapse or death from any cause (whichever comes first), Relapse Free Survival, RFS, i.e. the time from achievement of complete remission until hematological relapse, or death from any cause (whichever comes first), only for patients achieving CR, Rate of allogeneic hematopoietic stem cell transplantation, Quality of life, QoL Impact of treatment assessed by using the validated questionnaires EORTC QLQ-C30 and EQ-5D-5L, All AEs and SAEs during induction cycle 1, and possibly induction cycle 2, and consolidation cycles will be collected, CTC-graded, and MEDRA coded. Incidence proportions will be calculated.

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Countries

Germany

Outcome results

None listed