Phase 2 study of the Safety and Efficacy of ADCT-402 on DLBCL Patients
Research type
Research Study
Full title
A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
IRAS ID
246434
Contact name
Kirit Ardeshna
Contact email
Sponsor organisation
ADC Therapeutics SA
Eudract number
2017-004288-11
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 5 months, 1 days
Research summary
Lymphoma is a type of cancer that develops in the lymphatic system, a network of vessels that comprise part of the body’s immune system. It is characterised by an abnormal multiplication of infection-fighting white blood cells called lymphocytes. Diffuse Large B-Cell Lymphoma (DLBCL) is an aggressive type of lymphoma that develops from B-lymphocytes.
Chemo-immunotherapy, with or without radiotherapy is the most common initial therapy for DLBCL. Although response to initial treatment is high, a significant proportion of patients relapse (their cancer reoccurs). The current standard of care for relapsed DLBCL is additional chemotherapy, which can be followed by stem cell transplantation (SCT). The poor prognosis for relapsed patients, especially those with chemo-refractory (resistant to chemotherapy) disease with a short interval between remission (absence of cancer) and relapse, or those who relapse after high-dose therapy and SCT, highlights the unmet needs for patients with relapsed or refractory DLBCL.
The primary objective of this study is to evaluate the safety and efficacy profile of loncastuximab tesirine (ADCT-402), an experimental medication designed to target and destroy CD19-expressing (a kind of protein presented on the surface of the cell) malignant B-lymphocytes. Approximately 140 participants will be enrolled. Participants may continue treatment up to one year or until disease progression or some other factor that necessitates discontinuation of treatment occurs.
Participants will be required to visit the study site up to 3 times every three weeks (3 weeks = one cycle) and will receive loncastuximab tesirine via intravenous infusion once every cycle whilst on the study.Participants will undergo various tests and procedures including blood and urine tests, electrocardiograms, computed tomography (CT) scans, position emission tomography (PET scans), magnetic resonance imaging (MRI) scans and physical examinations to monitor their disease.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0197
Date of REC Opinion
16 Jul 2018
REC opinion
Further Information Favourable Opinion