Chronic Lymphocytic Leucemia Clinical Trial
Official title:
A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 and Ibrutinib (BIG) Followed by GA101 and Ibrutinib Maintenance in CLL Patients (CLL2-BIG Protocol)
Verified date | May 2019 |
Source | German CLL Study Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective, open-label, multicenter Phase-II trial to evaluate the efficacy and safety of a sequential regimen of Bendamustine followed by GA101 and Ibrutinib followed by Ibrutinib and GA101 maintenance in CLL patients.
Status | Completed |
Enrollment | 66 |
Est. completion date | March 29, 2019 |
Est. primary completion date | August 22, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. documented CLL requiring treatment (irrespective if first- or relapse treatment) according to the criteria of the international Workshop of CLL [iwCLL] In case of previously treated patients, these must have recovered from acute toxicities and treatment regimen must be stopped within the following time periods before start of the study treatment in the CLL2-BIG trial: - chemotherapy within = 28 days - antibody treatment within = 14 days - kinase inhibitors, B-cell-lymphoma 2 [BCL2] -antagonists or immunomodulatory agents within = 3 days - corticosteroids may be applied until the start of the BIG-regimen, these have to be reduced to an equivalent of = 20mg prednisolon during treatment 2. Creatinine clearance = 30 ml/min 3. Adequate hematologic function 4. Adequate liver function 5. Negative serological testing for hepatitis B, hepatitis-C RNA and negative HIV test within 6 weeks prior to registration 6. Age at least 18 years 7. Eastern Cooperative Oncology Group [ECOG] status 0 - 2; ECOG 3 is only permitted if related to CLL 8. Life expectancy = 6 months 9. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: 1. Transformation of CLL 2. Known central nervous system (CNS) involvement 3. Patients with a history of confirmed progressive multifocal leukoencephalopathy [PML] 4. Malignancies other than CLL currently requiring systemic therapies 5. Uncontrolled infection requiring systemic treatment 6. Use of investigational agents which would interfere with the study drug within 28 days prior to registration 7. Any comorbidity or organ system impairment rated with a cumulative illness rating scale [CIRS] 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 investigatorĀ“s opinion could comprise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g, inability to swallow tablets or impaired resorption in the gastrointestinal tract) 8. Known hypersensitivity to GA101, ibrutinib or any of the excipients 9. Requirement of treatment with strong cytochrome P450 3A4 [CYP3A4] -inhibitors/-inducers or anticoagulant with warfarin or phenprocoumon (marcumar) 10. History of stroke or intracranial hemorrhage within 6 months prior to registration 11. Pregnant women and nursing mothers 12. Fertile men or women of childbearing potential unless:surgically sterile or = 2 years after the onset of menopause or 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 18 months after end of study treatment. 13. Vaccination with a live vaccine a minimum of 28 days prior to registration 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 |
Country | Name | City | State |
---|---|---|---|
Germany | German CLL Study Group | Cologne |
Lead Sponsor | Collaborator |
---|---|
German CLL Study Group | Hoffmann-La Roche, Janssen-Cilag Ltd. |
Germany,
von Tresckow J, Cramer P, Bahlo J, Robrecht S, Langerbeins P, Fink AM, Al-Sawaf O, Illmer T, Klaproth H, Estenfelder S, Ritgen M, Fischer K, Wendtner CM, Kreuzer KA, Stilgenbauer S, Böttcher S, Eichhorst BF, Hallek M. CLL2-BIG: sequential treatment with b — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rate (ORR) | proportion of patients responding according to international working Group on chronic lymphocytic leukemia criteria | 84 days after first dose of last induction cycle | |
Secondary | Safety: Adverse events (AEs) and adverse events of special interest (AESI) | Type, frequency, and severity of adverse events (AEs) and adverse events of special interest (AESI) and their relationship to study treatment. | up to 48 months after first dose of study drug | |
Secondary | minimal residual disease (MRD) | Rate of MRD responses in peripheral blood measured by immunophenotyping | final restaging and during maintenance |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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