A Phase Ib Trial With Dose Expansion Evaluating CPX-351 Plus Gemtuzumab Ozogamicin for Relapsed Acute Myelogenous Leukemia
This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia that has come back after it was previously in remission. CPX-351 is a chemotherapy, which works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to chemotherapy called calicheamicin. Gemtuzumab attaches to CD33 (transmembrane receptor) positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving CPX-351 and gemtuzumab ozogamicin may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.
• Bone marrow blasts \>= 5% that develops after remission, no restriction on prior number of relapses or regimens
• Eastern Cooperative Oncology Group (ECOG) 0-2
• At least a 3-month duration of remission prior to relapse
• Participants with relapse after allogeneic transplantation are included
• Up to 1 cycle of hypomethylating agent monotherapy at time of relapse is allowed, must be discontinued at least 14 days prior to start of salvage induction
• Serum total bilirubin =\< 2.0 mg/dL, unless considered due to Gilbert?s disease or leukemia involvement
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 times the upper limit of normal, unless considered due to leukemia involvement
• Alkaline phosphatase =\< 3 times the upper limit of normal, unless considered due to leukemia involvement
• Serum creatinine =\< 2.0 mg/dL, or creatinine clearance \> 40 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR)
• Ability to give full informed consent on their own
• Females of reproductive potential (postmenopausal for less than 24 consecutive months) must have a negative pregnancy