GALACTIC version 1.0
Research type
Research Study
Full title
GALACTIC: GA-101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL
IRAS ID
153953
Contact name
Jamie Oughton
Contact email
Eudract number
2014-000880-42
Duration of Study in the UK
9 years, 0 months, 1 days
Research summary
Chronic lymphocytic leukaemia (CLL) is the most common leukaemia; most patients requiring therapy die from their disease. Most patients with CLL respond to chemotherapy but CLL cells are almost always detectable (known as minimal residual disease, MRD) and relapse is inevitable. Patients achieving MRD negativity(undetectable CLL) have better survival compared to MRD positive patients regardless of the treatment received, including chemotherapy, immunotherapy and stem cell transplantation.
Obinutuzumab is a novel anti-CD20 with more activity than previous anti-CD20 antibodies, and therefore consolidation after chemotherapy, when there is no bulky disease, appears to be the most likely possibility of eradicating MRD. Early response data appears to support this activity.The aims of this trial are to assess whether obinutuzumab consolidation after chemotherapy for CLL results in improved remissions and prolonged survival. This Phase II/III randomised trial will test whether consolidation with intravenous obinutuzumab at 3-12 months after chemotherapy reduces levels of MRD, leading to prolonged progression-free survival.
Aims:
The primary objective is to determine whether consolidation therapy with obinutuzumab improves progression-free survival compared to no consolidation therapy. There will also be an early phase II assessment to investigate the rate of MRD negativity, to determine the continuation of recruitment into the trial.
Secondary objectives are to compare the following between the trial arms: eradication of MRD; overall survival; treatment-free survival; overall survival; duration of MRD negativity; safety and toxicity of obinutuzumab and quality of life.
Methods:
This is a phase II/III, multi-centre, randomised, controlled, open parallel group trial in B-CLL patients who have recently responded to chemotherapy. Patients will be randomised to receive consolidation therapy with obinutuzumab or not.This study will demonstrate the role of consolidation with obinutuzumab following chemotherapy and further establish the importance of achieving the best possible depth of remission, including the eradication of detectable MRD, in CLL.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1199
Date of REC Opinion
12 Nov 2014
REC opinion
Further Information Favourable Opinion