TEAM-Trial: Targeting Epigenetic Therapy Resistance in AML With Bortezomib

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 22, 2019

Primary Completion Date

February 28, 2023

Study Completion Date

March 24, 2023

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Bortezomib

Bortezomib is a small molecule dipeptide binding the catalytic site of the 26 S proteasome. It acts as a potent, reversible, and specific inhibitor of proteasomes and thus impairs the degradation of ubiquitinated proteins. It has demonstrated anti-neoplastic activity in myeloma and lymphoma. It is approved and widely used in multiple myeloma both for first line treatment and relapsed patients.

DRUG

Gemtuzumab Ozogamicin

Gemtuzumab Ozogamicin is a monoclonal antibody directed against the myeloid surface antigen CD33. The antibody is linked to calicheamicin which serves as cytotoxic agent. For years, gemtuzumab ozogamicin has been tested in clinical AML trials. Though withdrawn from the US market in 2010, FDA approval was granted in September 2018, EU approval in April 2018 based on encouraging results from recent clinical trials using enhanced dosing schedules.

Trial Locations (1)

69120

University Hospital Heidelberg, Internal Medicine V, Heidelberg

All Listed Sponsors
collaborator

National Center for Tumor Diseases, Heidelberg

OTHER

lead

University Hospital Heidelberg

OTHER

NCT04173585 - TEAM-Trial: Targeting Epigenetic Therapy Resistance in AML With Bortezomib | Biotech Hunter | Biotech Hunter