Safety and Efficacy of CC-90009 combinations in patients with AML
Research type
Research Study
Full title
An Exploratory Phase 1b Open-label Multi-arm Trial to Evaluate the Safety and Efficacy of CC 90009 in Combination with Anti-Leukemia Agents in Subjects with Acute Myeloid Leukemia
IRAS ID
274658
Contact name
Paresh Vyas
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2019-001681-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 17 days
Research summary
Research Summary:
This is an open label, multi arm, parallel multi cohort, multicentre, phase 1b study evaluating the safety, toleribility, pharmacokinetics and efficacy if CC-90009 in combination with anti-leukaemia agents used for the treatment of acute myeloid leukaemia (AML). CC-90009 will be given as a combination therapy to patients with newly diagnosed or relapsed refractory AML. In this study various drug combinations with CC-90009 will be evaluated and each combination will be evaluated separately.
The study will consist of 2 parts: dose finding (Part A) and dose expansion (Part B)
- Arm A: CC-90009 in combination with venetoclax and azacitidine
- Arm B: CC-90009 in combination with gilteritinib
- Other combinations of CC-90009 and anti-leukemia agents may be explored in
subsequent protocol amendments.
Approximately 66 patients will be enrolled worldwide, the total study duration is expected to be approximately 3 to 4 years.Lay Summary:
Lay summary of study results are provided to the Investigators to pass on to the patients in the form of plain language summary (PLS).REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0133
Date of REC Opinion
9 Jun 2020
REC opinion
Further Information Favourable Opinion