Phase 1 Study of ADI plus Low Dose Cytarabine in older AML patients
Research type
Research Study
Full title
Phase 1 Study of ADI-PEG 20 Plus Low Dose Cytarabine in Older Patients with Acute Myeloid Leukemia
IRAS ID
240875
Contact name
David Taussig
Contact email
Sponsor organisation
Polaris Pharmaceuticals, Inc.
Eudract number
2016-003251-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND120345, Investigational New Drug Application
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The study is researching the safety and tolerability of ADI-PEG 20 given in combination with chemotherapy drug cytarabine at a low dose. The therapeutic area under investigation is acute myeloid leukemia (AML).
AML patients who are unfit for conventional intensive chemotherapy are eligible for this study. This includes patients with refractory or relapsed disease, or untreated patients with intermediate/adverse risk karyotype, i.e. chromosomal abnormalities which makes a patient not tolerate intensive chemotherapy. The study sites are Royal Marsden Hospital, St Bartholomew's Hospital and University College London Hospital in UK. The anticipated treatment period on the combination therapy is 8 weeks with a possible extension for patients with stable disease or better for up to 24 cycles (4 weeks per cycle). Patients with complete remission (CR, CRI or CCR) may receive up to 4 additional cycles of ADI-PEG 20 treatment after response. On treatment participants will have weekly visits for blood draws and study drug administration. Routine standard care procedures will be done as clinical indicated. Study is anticipated to last for about 2 years.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/0728
Date of REC Opinion
21 Jun 2018
REC opinion
Further Information Favourable Opinion