CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 326 enrolled
Drug / intervention
Decitabine 20 mg/m^2 +1 moredrug
Likely dose
Decitabine 20 mg/m^2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02472145
NCT02472145Phase 3Completed
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted Jun 15, 2015·Updated Mar 19, 2019

In Brief

A Phase 3 clinical trial evaluating Decitabine 20 mg/m^2 and Talacotuzumab 9 mg/kg for Leukemia, Myeloid, Acute. Completed, enrolled 326 participants across 81 sites in 14 countries.

Detailed Summary

The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute
CountriesAustralia, Belgium, France, Germany, Israel, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 15, 2015
Enrollment StartAug 4, 2015
Primary CompletionJan 25, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.0 years ago

Interventions

Decitabine 20 mg/m^2drug

Decitabine 20 milligram per square meter (mg/\[m\^2\]) from Day 1, 2, 3, 4 and 5 of a 28-day cycle.

Talacotuzumab 9 mg/kgdrug

Talacotuzumab 9 milligram per kilogram mg/kg on Day 8 and 22 of a 28-day cycle.