A Randomized Ph. 2/3 Study of DACOGEN® & JNJ-5602247 vs DACOGEN® alone
Research type
Research Study
Full title
A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus JNJ-56022473 (Anti CD123) Versus DACOGEN (Decitabine) Alone in Patients with AML who are not Candidates for Intensive Chemotherapy
IRAS ID
202024
Contact name
Steven Knapper
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2015-001611-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ERI-91414970,2.0, EDMS
Duration of Study in the UK
3 years, 1 months, 7 days
Research summary
This is an open label randomised phase 2/3 study comprising Part A and Part B. Part A of the study is already being undertaken outside of the UK. The objectives of Part A are to assess safety and confirm the recommended phase 2 dose (RP2D) of JNJ-5602247 mono-therapy. This application is relevant to Part B only. Part B of the study aims to enrol 400 subjects randomised 1:1 (200 in each arm) to either decitabine and JNJ-5602247 or decitabine alone. The population will comprise of subjects with AML who are not candidates for intensive chemotherapy. For subjects randomized to the decitabine & JNJ 56022473 arm, JNJ 56022473 will be administered intravenously at the RP2D determined in Part A on Day 8 and Day 22 every 28 days. Treatment is continued until treatment failure, relapse from response, unacceptable toxicity, or death.The first interim analysis will occur after 80 subjects (~ 40 subjects per arm) have been randomized and followed for at least 4 months. An Independent Data Monitoring Committee will recommend whether the study continues enrolment to the pre specified Phase 3 sample size of 400 subjects or discontinues enrolment. Approximately 120 subjects are expected to have been randomized by the time the outcome of the interim analysis is available; this is the estimated Phase 2 sample size.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0246
Date of REC Opinion
16 May 2016
REC opinion
Favourable Opinion