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NCT02472145 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 326
- Enrollment target
NCT02472145: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT02472145 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 326 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (145% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02472145, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 326 participants
- Enrollment target
Study 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.
Primary Outcome
Complete response rate defined as percentage of participants who achieved complete response as per modified International Working Group (IWG) criteria. CR: Bone marrow blasts less than (\<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0\*10\^9/liter (L) (1000/micro liter \[mcL\]); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as p
Interventions
- DRUG Decitabine 20 mg/m^2
- DRUG Talacotuzumab 9 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2015-08-04 |
| Est. Completion | 2018-01-25 |
| Phase | Phase 2 |
What the finished NCT02472145 record still lists
NCT02472145 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (145% higher).
The record links to 0 conditions, and to 2 interventions - of which Decitabine 20 mg/m^2 is the first listed.
NCT02472145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02472145 about?
NCT02472145 is a clinical study titled "An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy". 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 as...
What is the current status of trial NCT02472145?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 326 participants. The study started on 2015-08-04. Estimated completion is 2018-01-25.
What interventions are being tested in trial NCT02472145?
The interventions under investigation include: Decitabine 20 mg/m^2 (DRUG), Talacotuzumab 9 mg/kg (DRUG).
Who is sponsoring clinical trial NCT02472145?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02472145's enrollment target sits among peer trials
326 147th of 2000 higher than 1,853 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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