A Study of Experimental Combination of CPX-351 and Gemtuzumab Ozogamicin For Relapsed Acute Myeloid Leukemia

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: acute myeloid leukemia, blood cancer, leukemia
Type: Drug study, Phase 1
Target:
5 Participants
Investigator:
Description
This study will test the experimental combination of two FDA-approved therapies. We will test CPX-351 (also known as Vyxeos) and Gemtuzumab Ozogamicin (also known as Mylotarg).

CPX-351 (CPX) is a chemotherapy given through a vein. It is approved for newly diagnosed AML. CPX is a therapy that contains the two chemotherapies daunorubicin and cytarabine. These are the standard chemotherapies that are used in induction therapy for AML.

Gemtuzumab Ozogamicin (GO) is a targeted therapy against a protein called “CD33.” This protein is found on 90% of leukemia cells in patients with AML.

The combination of these two therapies is considered experimental. This study involves research that tests the safety and effectiveness of giving patients both of these therapies. The main purpose of the study is to determine if this combination of therapy is safe. We know that each therapy individually is safe, but the safety of the combination in relapsed AML is unknown at this time.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • 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

Exclusion criteria:

  • Currently receiving targeted therapy for FLT3 (cytokine receptor tyrosine kinase class III), IDH1, or IDH2 (isocitrate dehydrogenase, 1, 2) mutations and intent to continue use; prior use of targeted therapy for such mutations is allowed, but agents should be discontinued 1 week prior to enrollment
  • Acute promyelocytic leukemia
  • Second malignancy that would limit survival by less than 2 years
  • New York Heart Association class III or VI
  • Left ventricular ejection fraction < 50%
  • History of coronary stent placement that requires mandatory continuation of dual-antiplatelet therapy
  • History of Wilson?s disease or other copper handling disorders
  • Hypersensitivity to cytarabine, daunorubicin, or liposomal products
  • Active invasive fungal infection
  • Active bacterial or viral infection manifesting as fevers or hemodynamic instability within the past 72 hours
  • Lifetime cumulative daunorubicin-equivalent anthracycline dose > 368 mg/m^2
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
This study will last 18 months.
Recruitment period
From July 22, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Contact
Micaela Rodriguez
Research Topic
Conditions:
  • Acute Myelogenous Leukemia

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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