Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG)
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ClinicalTrials.gov Identifier: NCT02401503 |
Recruitment Status :
Active, not recruiting
First Posted : March 27, 2015
Last Update Posted : August 24, 2021
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Condition or disease | Intervention/treatment | Phase |
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Chronic Lymphocytic Leucemia | Drug: Bendamustine Drug: GA101 Drug: ABT-199 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 ABT-199 Followed by ABT-199 and GA101 Maintenance in CLL Patients |
Actual Study Start Date : | May 6, 2015 |
Actual Primary Completion Date : | December 13, 2016 |
Estimated Study Completion Date : | September 2022 |

Arm | Intervention/treatment |
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Experimental: Bendamustine + GA101 + ABT-199
Bendamustine: 70mg/m² i.v. GA101: 1000 mg i.v. ABT-199: 20 - 400 mg p.o.
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Drug: Bendamustine
Debulking: Cycles 1-2, d1 & 2: 70mg/m² i.v. Drug: GA101 Induction: Cycle 1: d1: 100mg, d1(or 2): 900mg, d8 & 15: 1000mg; Cycle 2-6: d1: 1000mg Maintenance: Cycles 1-8 (Duration 12 weeks): d1: 1000mg
Other Name: Obinutuzumab Drug: ABT-199 Induction: Cycle 2: d1-7: 20mg, d8-14: 50mg, d15-21: 100mg, d22-28: 200mg; Cycle 3-6: d1-28: 400mg Maintenance: Cycles 1-8 (Duration 12 weeks): d1-84: 400mg
Other Name: Venetoclax, GDC-0199 |
- Overall response rate (ORR) [ Time Frame: 84 days after start of the last cycle of induction therapy ]Proportion of patients responding according to international working Group on chronic lymphocytic leukemia criteria
- Adverse Events (AEs) and adverse events of special interest (AESI) [ Time Frame: up to 40 months after first dose of study drug ]Type, frequency and severity of adverse events (AEs) and adverse events of special interest (AESI) and their relationship to study treatment
- Rate of minimal residual disease (MRD) [ Time Frame: up to 40 months ]Rate of MRD responses in peripheral blood measured by immunophenotyping

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- documented chronic lymphocytic leukemia (CLL) requiring treatment according to International Working Group on CLL (iwCLL) criteria
- 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 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 liver function: total bilirubin ≤2x, 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)
- requirement of therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors/inducers or anticoagulant with warfarin, phenprocoumon (marcumar) or other vitamin K-antagonists
- use of investigational agents within 28 days prior to registration
- known hypersensitivity to GA101 (obinutuzumab), ABT-199 (venetoclax, GDC-0199) 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401503
Germany | |
German CLL Study Group | |
Cologne, Germany, 50935 |
Principal Investigator: | Paula Cramer, Dr. med. | German CLL Study Group |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | German CLL Study Group |
ClinicalTrials.gov Identifier: | NCT02401503 |
Other Study ID Numbers: |
CLL2-BAG 2014-000580-40 ( EudraCT Number ) |
First Posted: | March 27, 2015 Key Record Dates |
Last Update Posted: | August 24, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
CLL |
Bendamustine Hydrochloride Venetoclax Obinutuzumab Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Immunological |