A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia who are not Candidates for Intensive Chemotherapy

Conditions

Acute Myeloid Leukemia

Brief summary

Complete response (CR) rate per ELN 2017 (Dohner 2017)

Detailed description

Rate of CRh, Rate of CR + CRh, Rate of Cri, Overall response rate (ORR) = Rate of CR+ CRh+ CRi, Rate of CR without MRD, Rate of MRD negativity among participants achieving CR, CRh, CRi, or MLFS; defined as less than 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level <10^-3), Time to response, defined as time from randomization in Part 1 or enrollment in Part 2 to achieving the first response of CR, CRh, or CRi; duration of response, defined as time from achieving the first response of CR, CRh, or CRi to disease relapse or death from any cause., Transfusion independence (RBC or platelets) is defined as a period of at least 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug + 30 days., Safety profile of Adverse Events (AE) and Serious Adverse Events (SAE), Pharmacokinetics, Immunogenicity / anti-drug antibody testing

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Interventions

DRUGCusatuzumab

DRUGAZACITIDINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete response (CR) rate per ELN 2017 (Dohner 2017)	—

Secondary

Measure	Time frame
Rate of CRh, Rate of CR + CRh, Rate of Cri, Overall response rate (ORR) = Rate of CR+ CRh+ CRi, Rate of CR without MRD, Rate of MRD negativity among participants achieving CR, CRh, CRi, or MLFS; defined as less than 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level <10^-3), Time to response, defined as time from randomization in Part 1 or enrollment in Part 2 to achieving the first response of CR, CRh, or CRi; duration of response, defined as time from achieving the first response of CR, CRh, or CRi to disease relapse or death from any cause., Transfusion independence (RBC or platelets) is defined as a period of at least 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug + 30 days., Safety profile of Adverse Events (AE) and Serious Adverse Events (SAE), Pharmacokinetics, Immunogenicity / anti-drug antibody testing	—

Measure

Time frame

Rate of CRh, Rate of CR + CRh, Rate of Cri, Overall response rate (ORR) = Rate of CR+ CRh+ CRi, Rate of CR without MRD, Rate of MRD negativity among participants achieving CR, CRh, CRi, or MLFS; defined as less than 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level <10^-3), Time to response, defined as time from randomization in Part 1 or enrollment in Part 2 to achieving the first response of CR, CRh, or CRi; duration of response, defined as time from achieving the first response of CR, CRh, or CRi to disease relapse or death from any cause., Transfusion independence (RBC or platelets) is defined as a period of at least 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug + 30 days., Safety profile of Adverse Events (AE) and Serious Adverse Events (SAE), Pharmacokinetics, Immunogenicity / anti-drug antibody testing

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Countries

Spain

Outcome results

None listed