GA101 (obinutuzumab) monoclonal antibody as consolidation therapy In CLL

ISRCTN	ISRCTN64035629
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

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-whether-obinutuzumab-after-chemotherapy-for-cll-can-reduce-the-chances-of-the-leukaemia-coming-back-galactic

Contact information

Mr Jamie Oughton
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
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
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

Sponsor information

University of Leeds
Hospital/treatment centre

Faculty of Medicine and Health
Academic Unit of Musculoskeletal and Rehabilitation Medicine
36 Clarendon Road
Leeds
LS2 9NZ
England
United Kingdom

"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Government

Cancer Research UK
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
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.