Gemtuzumab Ozogamicin for Relapsed/Refractory AML

Relapsed and refractory acute myeloid leukemia (AML) is a devastating diagnosis with a very low five-year survival rate. Fortunately, researchers are constantly exploring new and improved treatment options. This article explores the potential of gemtuzumab ozogamicin (GO) for patients with relapsed/refractory AML.

What is Gemtuzumab Ozogamicin (GO)?

Gemtuzumab Ozogamicin (Mylotarg, Pfizer) is an anti-CD33 antibody-drug conjugate. This means it targets a protein called CD33, found on the surface of many AML cells. The antibody delivers a chemotherapy drug directly to the cancer cells, potentially increasing its effectiveness while minimizing side effects on healthy tissues.

A large majority of AML diagnoses express the CD33 antigen. Gemtuzumab ozogamicin is an anti-CD33 monoclonal antibody. It is “FDA approved for patients with AML who cannot tolerate intensive chemotherapy, and additionally received FDA approval in the RR-AML setting on the basis of a modest complete response (CR) rate of 26%.” 

Gemtuzumab ozogamicin is optimal for newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older and adults and children who are 2 years old or older, and who have CD33-positive AML that is relapsed or refractory.

The following are all clinical trials using gemtuzumab ozogamicin:

Several clinical trials are investigating the effectiveness and safety of GO combined with other treatments for relapsed/refractory AML. Here are some ongoing and completed trials:

GO in combination with liposomal cytarabine and daunorubicin

• 18 pediatric patients with relapsed/refractory AML - Phase I trial recruiting
• 50 patients with relapsed/refractory AML or high-risk MDS - Phase II trial recruiting

GO with fludarabine/cytarabine with or without venetoclax

• This is a trial for children, adolescents, and young adults with 2nd relapsed AML or 1st relapsed AML unable to receive additional anthracycline.
• Phase III trial recruiting 98 participants

GO and midostaurin with standard chemotherapy

• This is a dose-finding study to identify the maximum tolerated dose (MTD) schedule of GO and its safety and tolerability in combination with midostaurin in FLT3-mutated newly diagnosed AML patients.
• Phase I recruiting 18 patients

GO combined with chemotherapy in newly diagnosed AML

• This Phase II evaluates the safety of a regimen incorporating fludarabine phosphate (fludarabine), high-dose cytarabine, filgrastim-sndz,  idarubicin hydrochloride (idarubicin), and GO in patients with untreated inv(16) or t(8;21) AML.
• Recruiting 270 patients

To continue exploring open clinical trials for AML patients, use the Healthtree's Clinical Trial Finder HERE

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