The purpose of the study is to determine the safety of combining the drugs gemtuzumab ozogamicin (GO) with CPX-351 in order to treat the disease, as well as to find the maximum tolerated dose level and recommended Phase 2 dose level of GO with a fixed dose of CPX-351.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Fixed dose of Vyxeos (44 mg/m2 daunorubicin and 100 mg/m2 cytarabine) (Day 1, 3, and 5) in combination with various dose schedules of Gemtuzumab Ozogamicin (GO)
Participants will be treated at the following dose levels: Dose Level 1 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1 Dose Level 2 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1 and 4 Dose Level 3 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1, 4, 7
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGMaximum Tolerated Dose (MTD)
Dose escalation will determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Vyxeos plus Gemtuzumab Ozogamicin. The MTD is the highest dose of the combination therapy that dose not cause unacceptable side effects.
Time frame: Up to 18 Months
Rate of Complete Remission
Rate of complete remission (CR) and complete remission with incomplete blood count recovery (CRi). The definition of CR and CRi is based on the European LeukemiaNet 2017 Response Criteria for AML.
Time frame: Up to 18 Months
Measurable Residual Disease
Rate of measurable residual disease via RT-PCR for core binding factor leukemia as well as NPM1 mutated AML
Time frame: Up to 18 Months
Overall Survival
Overall survival is defined as the duration of time from start of treatment to the time of death from any cause or date of last contact.
Time frame: Up to 5 years
Relapse Free Survival (RFS)
RFS is defined as time interval between achievement of CR to time of relapse
Time frame: Up to 18 Months
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