Condition category
Cancer
Date applied
08/01/2015
Date assigned
12/01/2015
Last edited
01/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mr Jamie Oughton

ORCID ID

Contact details

Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
Leeds
LS2 9JT
United Kingdom

Additional identifiers

EudraCT number

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 below 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 measures

Progression free survival (phase III); Timepoint(s): Disease progression or death

Secondary outcome measures

N/A

Overall trial start date

15/12/2014

Overall trial end date

17/09/2018

Reason abandoned

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

17/09/2018

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

Sponsor information

Organisation

University of Leeds

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes