A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus Talacotuzumab (JNJ-56022473 Anti-CD123) Versus DACOGEN (Decitabine) Alone in Patients with AML who are not Candidates for Intensive Chemotherapy
The goal of this clinical research study is learn if decitabine in combination with talacotuzumab (JNJ-56022473) can help to control AML. The safety of this drug combination will also be studied and will be compared to decitabine alone. This is the second part of a 2-part study. In the first part of the study, the highest tolerable dose of talacotuzumab was found and will be used in this part.
Treatment Location: N/A
Primary Objectives Part A: to assess the safety of talacotuzumab monotherapy and confirm the RP2D in subjects with AML for whom experimental therapy is appropriate (as assessed by their treating physician). Part B: The primary objectives of the study are to assess complete response (CR) rate and overall survival (OS) in subjects with previously untreated AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone. Secondary Objectives (Part B) The secondary objectives are: To assess event-free survival (EFS) To determine the overall response rate (ORR) defined as rate of complete response (CR) and complete response with incomplete blood count recovery (CRi) To determine the rate of CR plus MRD negative CRi To assess the relapse-free survival (RFS) To assess time to response and duration of response for subjects who achieve CR/CRi To assess minimal residual disease (MRD) To assess the safety profile of talacotuzumab in combination with decitabine To assess the pharmacokinetics of talacotuzumab and decitabine alone and in combination To assess the immunogenicity of talacotuzumab alone (Part A) and in combination with decitabine (Part B) To assess patient-reported outcomes (PROs) using the FACT-Leu and EQ-5D-5L. Exploratory Objectives The exploratory objectives are: To explore PK/PD relationships of talacotuzumab through analysis of talacotuzumab PK, biomarkers, PD markers, and clinical end points To explore biomarkers predictive of clinical response To collect medical resource utilization (MRU) data that may be used in future economic modeling (the construction and reporting of the economic model will be conducted separately from this study.
IRB Review and Approval Date: 01/04/2016
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Phase II/Phase III
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