Additional identifiers
EudraCT number
2014-000880-42
ClinicalTrials.gov number
Protocol/serial number
17787
Study information
Scientific title
GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL: a randomised controlled trial
Acronym
GALACTIC
Study hypothesis
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
14/YH/1199
Study design
Randomised; Interventional
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
Obinutuzumab
Primary outcome measure
Progression free survival (phase III); Timepoint(s): Disease progression or death
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/12/2014
Overall trial end date
17/09/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 188; UK Sample Size: 188
Participant 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.
Recruitment start date
06/02/2015
Recruitment end date
24/02/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom
Funders
Funder type
Government
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28747208