REMoDL-A
Research type
Research Study
Full title
A randomised Phase II Evaluation of Molecular Guided Therapy for Diffuse Large B-Cell Lymphoma with Acalabrutinib
IRAS ID
266600
Contact name
Andrew Davies
Contact email
Eudract number
2020-000998-25
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
RHM CAN1500, Sponsor Number
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
Diffuse large B-cell lymphoma (DLBCL) is the most common of the non-Hodgkin’s lymphomas. Whilst the majority of patients will respond well to conventional treatment (R-CHOP a type of immunochemotherapy), a significant number of patients lymphoma will not respond to initial therapy or their disease will return after completion of therapy. In a number of B-cell diseases an enzyme called, Bruton tyrosine kinase (BTK) prevents death of tumour cells, including in DLBCL. Acalabrutinib is an orally active BTK-inhibitor and it is thought that stopping BTK being activated may help in treating B-cell diseases. It is hypothesised that the addition of Acalabrutinib to standard R-CHOP immunochemotherapy may improve outcomes of patients with DLBCL.
The main aims of this randomised phase II clinical study are:
- To determine if combining Acalabrutinib with R-CHOP improves efficacy, compared to R-CHOP alone, for the treatment of previously untreated patients with DLBCL.
- To compare progression-free survival, overall survival, event free survival, disease free survival, time to progression, response duration and overall response rate between both treatment and molecular groups.
- To assess differences in toxicity between the assigned treatments
- To assess differences in quality of life in different treatment arms
- To explore correlation of molecular characteristics in tumour material to clinical outcomes.
- To explore correlation of baseline PET features including metabolic tumour volume, tumour lesion glycolysis, extranodal sites and bone marrow involvement with clinical risk factor and molecular characteristics in tumour material.
- To compare metabolic response rates between molecular groups.
Up to 558 patients (453 randomised) will be recruited to the clinical trial with 302 patients randomised to the experimental arm and 151 to the control arm in a 2:1 randomisation.REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0122
Date of REC Opinion
26 Apr 2021
REC opinion
Favourable Opinion