Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

Titre officiel

An Open-label, Multicentre, Phase 1b Study of JNJ-74494550 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination With Background Therapy for the Treatment of Subjects With Acute Myeloid Leukemia

Sommaire:

The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).

Description de l'essai

Primary Outcome:

  • Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety
Secondary Outcome:
  • Serum Concentration of Cusatuzumab
  • Number of Participants with Anti-cusatuzumab Antibodies
  • Percentage of Participants with Complete Response (CR)
  • Percentage of Participants with Complete Remission with Partial Hematological Recovery (CRh)
  • Percentage of Participants with CR with Incomplete Recovery (CRi)
  • Percentage of Participants with CR plus CRh
  • Overall Response Rate (ORR)
  • Percentage of Participants with CR without MRD
  • Percentage of Participants with Negative MRD who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS)
  • Cohort 2 and 3: Time to Response
  • Cohort 2 and 3: Duration of Response
  • Cohort 2 and 3: Red Blood Cell (RBC) or Platelet Transfusion Independence

Voir cet essai sur ClinicalTrials.gov

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