GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) trial: study protocol for a phase II/III randomised controlled trial
| Autor: | Oughton, JB, Collett, L, Howard, DR, Hockaday, A, Munir, T, McMahon, K, McParland, L, Dimbleby, C, Phillips, D, Rawstron, AC, Hillmen, P |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
GA-101
Randomised controlled trial (RCT) lcsh:R5-920 Time Factors Chronic lymphocytic leukaemia (CLL) Phase II/III trial Antibodies Monoclonal Humanized Leukemia Lymphocytic Chronic B-Cell Disease-Free Survival United Kingdom Consolidation Chemotherapy Study Protocol Antineoplastic Agents Immunological Treatment Outcome Clinical Protocols Research Design hemic and lymphatic diseases Obinutuzumab Humans Minimal residual disease (MRD) lcsh:Medicine (General) Consolidation |
| Zdroj: | Trials, Vol 18, Iss 1, Pp 1-12 (2017) Trials Oughton, JB, Collett, L, Howard, D R, Hockaday, A, Munir, T, McMahon, K, McParland, L, Dimbleby, C, Phillips, D, Rawstron, A C & Hillmen, P 2017, ' GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) trial : study protocol for a phase II/III randomised controlled trial. ', Trials, vol. 18, 353 . https://doi.org/10.1186/s13063-017-2107-0 |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-017-2107-0 |
| Popis: | Background Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia. Achieving minimal residual disease (MRD) negativity in CLL is an independent predictor of survival even with a variety of different treatment approaches and regardless of the line of therapy. Methods/design GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) is a seamless phase II/III, multi-centre, randomised, controlled, open, parallel-group trial for patients with CLL who have recently responded to chemotherapy. Participants will be randomised to receive either obinutuzumab (GA-101) consolidation or no treatment (as is standard). The phase II trial will assess safety and short-term efficacy in order to advise on continuation to a phase III trial. The primary objective for phase III is to assess the effect of consolidation therapy on progression-free survival (PFS). One hundred eighty-eight participants are planned to be recruited from forty research centres in the United Kingdom. Discussion There is evidence that achieving MRD eradication with alemtuzumab consolidation is associated with improvements in survival and time to progression. This trial will assess whether obinutuzumab is safe in a consolidation setting and effective at eradicating MRD and improving PFS. Trial registration ISRCTN, 64035629. Registered on 12 January 2015. EudraCT, 2014-000880-42. Registered on 12 November 2014. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2107-0) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|