Vyxeos for Induction of Low- or Intermediate-risk.

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 7, 2022

Primary Completion Date

September 7, 2028

Study Completion Date

September 7, 2028

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Vyxeos

Vyxeos (daunorubicin and cytarabine) liposome for injection

DRUG

Mylotarg

Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanized immunoglobulin \[Ig\] G4, kappa antibody produced by mammalian cell culture in non-secreting 0 (NS0) cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin. Gemtuzumab ozogamicin consists of conjugated and unconjugated gemtuzumab. The conjugated molecules differ in the number of activated calicheamicin derivative moieties attached to gemtuzumab. The number of conjugated calicheamicin derivatives per gemtuzumab molecule ranges from predominantly zero to 6, with an average of 2 to 3 moles of calicheamicin derivative per mole of gemtuzumab.

Trial Locations (1)

9103102

Shaare Zedek Medical Center, Jerusalem

All Listed Sponsors
lead

Shaare Zedek Medical Center

OTHER