GA101 (obinutuzumab) monoclonal antibody as consolidation therapy In CLL
ISRCTN | ISRCTN64035629 |
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DOI | https://doi.org/10.1186/ISRCTN64035629 |
EudraCT/CTIS number | 2014-000880-42 |
Secondary identifying numbers | 17787 |
- Submission date
- 08/01/2015
- Registration date
- 12/01/2015
- Last edited
- 31/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mr Jamie Oughton
Scientific
Scientific
Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom
Study information
Study design | Randomised; Interventional |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL: a randomised controlled trial |
Study acronym | GALACTIC |
Study objectives | The trial will compare the use of obinutuzumab (GA101) in patients who have recently responded to treatment for chronic lymphocytic leukaemia (CLL) with the current standard practice, which is no treatment. The trial will evaluate whether obinutuzumab, if given after chemotherapy when there will be fewer CLL cells remaining, will keep patients disease free for longer. |
Ethics approval(s) | 14/YH/1199 |
Health condition(s) or problem(s) studied | Topic: Cancer; Subtopic: Haematological Oncology; Disease: Leukaemia(Chronic Lymphocytic Leukaemia) |
Intervention | Obinutuzumab, Intravenous infusion on days 1 & 2 then weekly (days 8, 15 and 22) and fortnightly (days 26, 50, 64, 78). Approx 3 months total. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Obinutuzumab |
Primary outcome measure | Progression free survival (phase III); Timepoint(s): Disease progression or death |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 15/12/2014 |
Completion date | 17/09/2018 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 188; UK Sample Size: 188 |
Key inclusion criteria | 1. At least 18 years old 2. Previous confirmation of B-CLL with a characteristic immunophenotype (for example, CD5+, CD19+, CD23+ lymphoproliferative disorder) on peripheral blood flow cytometry 3. Maximum of three prior therapies received for CLL treatment and between 3 and 24 months post therapy at registration 4. Response to most recent chemotherapy treatment for CLL with PR, CRi or CR 5. World Health Organisation (WHO) performance status (PS) of 0 or 1 6. Able to provide written informed consent 7. Peripheral B-Cell count <5x10^9 L 8. For randomisation, the first MRD positive peripheral blood sample (disease level found in peripheral blood is greater than 0.01%) must be between 3 and 12 months since completing most recent therapy for CLL 9. Absence of clinically or radiologically evident lymphadenopathy (largest lymph node 1.5 cm or less in minimum diameter) 10. Creatinine and bilirubin <2 times upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis Target Gender: Male & Female |
Key exclusion criteria | 1. Disease progression after response to latest therapy 2. Active infection 3. Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies 4. Previous treatment with obinutuzumab 5. CNS involvement with CLL 6. Mantle cell lymphoma 7. Moderate or severe cardiac disease that would preclude treatment with obinutuzumab 8. Other severe, concurrent diseases or mental disorders that could interfere with ability to participate 9. Known HIV positivity 10. Active secondary malignancy excluding basal cell carcinoma 11. Active haemolysis 12. Patients previously treated with allogeneic Stem Cell Transplant 13. Pregnancy, lactation or women of childbearing potential unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment has finished 14. Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment has finished, unless they are surgically sterile 15. Persisting severe pancytopenia (neutrophils <0.5 x 10^9/L or platelets <50 x 10^9/L) or trans fusion dependent anaemia 16. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. 17. Positive serology for Hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result. |
Date of first enrolment | 06/02/2015 |
Date of final enrolment | 24/02/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom
University of Leeds
Leeds
LS2 9JT
United Kingdom
Sponsor information
University of Leeds
Hospital/treatment centre
Hospital/treatment centre
Faculty of Medicine and Health
Academic Unit of Musculoskeletal and Rehabilitation Medicine
36 Clarendon Road
Leeds
LS2 9NZ
England
United Kingdom
https://ror.org/024mrxd33 |
Funders
Funder type
Government
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 26/07/2017 | Yes | No | |
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
31/07/2017: Publication reference added.
26/06/2017: The recruitment end date was changed from 17/09/2018 to 24/02/2017.