A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by GA101 and ibrutinib (BIG) followed by ibrutinib and GA101 maintenance in CLL patients (CLL2-BIG protocol)
- Conditions
- Fit and unfit patients with previously untreated or relapsed/refractory CLL requiring treatmentMedDRA version: 19.1 Level: PT Classification code 10008958 Term: Chronic lymphocytic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000569-35-DE
- Lead Sponsor
- niversity of Cologne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 62
1.Have documented CLL requiring treatment according to iwCLL criteria
2.Creatinine clearance = 30 ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured after 24 h urine collection
3.Adequate liver function as indicated by a total bilirubin = 2 x, AST, and ALT = 2.5 x the institutional ULN value, unless directly attributable to the patient’s CLL or to Gilbert’s Syndrome
4.Negative serological testing for hepatitis B (i.e. HBsAg negative and anti-HBc negative, patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 3 months after last dosage of GA101), negative testing for hepatitis-C RNA and negative HIV test within 6 weeks prior to registration
5.Age at least 18 years
6.ECOG 0 – 2; ECOG 3 is only permitted if related to CLL (e.g. due to anaemia or severe constitutional symptoms)
7.Life expectancy = 6 months
8.Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62
1.Transformation of CLL (i.e. Richter’s transformation, prolymphocytic leukaemia)
2.Known central nervous system (CNS) involvement
3.Patients with a history of confirmed PML
4.Malignancies other than CLL currently requiring systemic therapies
5.Use of investigational agents which would interfere with the study drug within 28 days prior to registration
6.Active infection requiring systemic treatment
7.Any comorbidity or organ system impairment rated with a CIRS (cumulative illness rating scale) score of 4, excluding the eyes/ears/nose/throat/larynx organ system or any other life-threatening illness, medical condition or organ system dysfunction that – in the investigator´s opinion could comprise the patients safety or interfere with the absorption or metabolism of the study drugs
8.Known hypersensitivity to GA101 (obinutuzumab), ibrutinib or any of the excipients
9.Requirement of treatment with strong CYP3A4-inhibitors/-inducers or anticoagulant with warfarin or phenoprocoumon (marcumar)
10.History of stroke or intracranial haemorrhage within 6 months prior to randomization
11.Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment)
12.Fertile men or women of childbearing potential unless:
a. surgically sterile or = 2 years after the onset of menopause
b.willing to use two methods of reliable contraception including one highly effective (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 12 months after end of study treatment.
13.Vaccination with a live vaccine a minimum of 28 days prior to randomization
14.Legal incapacity
15.Prisoners or subjects who are institutionalized by regulatory or court order
16.Persons who are in dependence to the sponsor or an investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method