Chronic Lymphocytic Leucemia Clinical Trial
Official title:
Prospective, Open-label, Multicenter Phase-II Trial to Evaluate Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by GA101 (Obinutuzumab) and CAL-101 (Idelalisib) Followed by CAL-101 and GA101 Maintenance in CLL Patients
Verified date | July 2023 |
Source | German CLL Study Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The CLL2-BCG-trial is a prospective, open-label, multicenter phase-II-trial to evaluate the efficacy and safety of a sequential regimen of a debulking with bendamustine followed by an induction with GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and GA101-maintenance in CLL patients
Status | Completed |
Enrollment | 48 |
Est. completion date | March 9, 2022 |
Est. primary completion date | March 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - documented chronic lymphocytic leukemia (CLL) requiring treatment according to International Working Group on CLL (iwCLL) criteria - adequate hematologic function: platelets = 25.000/µl, neutrophils = 1.000/µl and hemoglobin =8.0 g/dL, unless directly attributable to the patient´s CLL (e.g. bone marrow infiltration) - adequate renal function: a creatinine clearance =30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24 hr. urine collection - adequate liver function: total bilirubin =1,5x, aspartate aminotransferase (AST) / alanin aminotransferase (ALT) =2.5x the institutional upper limit of normal (ULN) value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome - negative serological testing for hepatitis B, negative testing for hepatitis-C RNA and negative HIV test within 6 weeks prior to registration - age = 18 years - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2, ECOG 3 is only permitted if related to CLL - life expectancy = 6 months - ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: - transformation of CLL (i.e. Richter's transformation, prolymphocytic leukemia) - known central nervous system (CNS) involvement - confirmed progressive multifocal leukoencephalopathy (PML) - malignancies other than CLL currently requiring systemic therapies - uncontrolled infection requiring systemic treatment - 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 investigator´s opinion - could compromise 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) - ongoing inflammatory bowel disease - ongoing drug induced pneumonitis - use of investigational agents which would interfere with the study drug =28 days prior to registration - known hypersensitivity to GA101 (obinutuzumab), CAL-101 (idelalisib) or any of the excipients - pregnant women and nursing mothers - 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 - vaccination with a live vaccine =28 days prior to registration - legal incapacity - prisoners or subjects who are institutionalized by regulatory or court order - 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 | Gilead Sciences, Hoffmann-La Roche |
Germany,
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 start of the last induction cycle | |
Secondary | 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 40 months after first dose of study drug | |
Secondary | Rate of minimal residual disease (MRD) | Rate of MRD responses in peripheral blood measured by immunophenotyping | up to 40 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02320383 -
CLLR3: Bendamustine + GA101 (BG) in Relapsed or Refractory CLL Followed by GA101 Maintenance for Responding Patients
|
Phase 2 | |
Active, not recruiting |
NCT02401503 -
Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG)
|
Phase 2 | |
Completed |
NCT02345863 -
Sequential Regimen of Bendamustin [B] Followed by GA101 and Ibrutinib [I] in CLL Patients
|
Phase 2 |