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clinical / clinicalCLL11 trial obinutuzumab chlorambucil, GCLLSG, elderly CLL, front-line

Barbara Eichhorst

芭芭拉·艾希霍斯特

MD

🏢University Hospital of Cologne(科隆大学医院)🌐Germany

Professor of Internal Medicine, Department I of Internal Medicine, Center of Integrated Oncology (CIO Aachen Bonn Cologne Düsseldorf), University Hospital of Cologne; Deputy Head, German CLL Study Group (GCLLSG)科隆大学医院内科一部教授;德国CLL研究组(GCLLSG)副组长

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Barbara Eichhorst, MD is Professor of Internal Medicine at the University Hospital of Cologne and Deputy Head of the German CLL Study Group (GCLLSG), one of the world's most productive and influential CLL cooperative clinical trial organizations. Prof. Eichhorst served as principal investigator of the landmark CLL11 trial (NEJM 2014), the phase III study that established obinutuzumab (GA101), a next-generation glycoengineered type II anti-CD20 antibody, as superior to rituximab when combined with chlorambucil in previously untreated CLL patients with comorbidities. CLL11 demonstrated that obinutuzumab plus chlorambucil achieved significantly improved PFS (HR 0.39; p<0.001) and MRD negativity rates compared with rituximab plus chlorambucil, and led to the first FDA approval of obinutuzumab in November 2013 — marking the first time a new drug for front-line CLL was approved based on superiority over an existing standard in over a decade. Prof. Eichhorst has been the central architect of GCLLSG's comprehensive trial program spanning fit, unfit, and high-risk CLL populations, including the CLL10 trial comparing FCR versus BR in fit patients, and the CLL2-BIG/BAG studies of venetoclax and ibrutinib-based induction strategies. She has co-authored the iwCLL guidelines for CLL response criteria and represents Germany in major international CLL collaborations. With over 250 publications, she is one of the most influential CLL clinical trialists in Europe.

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🧪Research Fields 研究领域

CLL11 Trial — Obinutuzumab plus Chlorambucil (Principal Investigator)CLL11试验——奥比努珠单抗联合苯丁酸氮芥(首席研究员)
German CLL Study Group (GCLLSG) — Clinical Trial Design and Leadership德国CLL研究组(GCLLSG)——临床试验设计与领导
Front-Line CLL Therapy in Elderly/Unfit Patients — Fit vs. Unfit Treatment Algorithms老年/不适合强化治疗CLL患者的一线治疗——适合与不适合治疗算法
Obinutuzumab Biology — Type II Anti-CD20 Antibody Mechanism in CLL奥比努珠单抗生物学——II型抗CD20抗体在CLL中的机制
CLL Treatment Response Criteria and MRD Assessment in Clinical Trials临床试验中CLL治疗反应标准与MRD评估

🎓Key Contributions 主要贡献

CLL11 Trial — Obinutuzumab plus Chlorambucil, Defining Anti-CD20 Hierarchy in CLL

Served as principal investigator of the phase III CLL11 trial (NEJM 2014) randomizing 781 CLL patients with comorbidities to obinutuzumab plus chlorambucil, rituximab plus chlorambucil, or chlorambucil alone, demonstrating obinutuzumab superiority over rituximab in combination with chlorambucil in terms of PFS (HR 0.39 vs. HR 0.55 for rituximab), CR rate, and MRD negativity. CLL11 led to FDA approval of obinutuzumab in November 2013 as the first drug to improve survival over an existing CLL standard, establishing the type II glycoengineered anti-CD20 as the preferred antibody partner in CLL combinations.

CLL10 Trial — FCR versus BR in Fit CLL Patients

Co-led the GCLLSG CLL10 trial comparing FCR (fludarabine, cyclophosphamide, rituximab) versus BR (bendamustine, rituximab) in 564 physically fit, previously untreated CLL patients, demonstrating FCR superiority in PFS (42.4 vs. 32.8 months; p<0.001) in the overall population, while identifying comparable outcomes for patients aged >65 and significantly greater FCR toxicity (myelosuppression, infections), providing the evidence base for age-stratified chemoimmunotherapy selection.

GCLLSG Venetoclax and BTK Inhibitor Induction Trials

Designed and co-led GCLLSG investigator-initiated trials exploring novel sequential and combination induction strategies, including the CLL2-BAG (bendamustine debulking plus ibrutinib plus venetoclax) and CLL2-BIG (ibrutinib plus venetoclax) trials, evaluating MRD-guided fixed-duration chemotherapy-free approaches in fit CLL patients aiming to achieve deep uMRD remissions with time-limited all-oral regimens.

iwCLL CLL Response Criteria and Clinical Trial Methodology

Co-authored the iwCLL (International Workshop on CLL) guidelines for CLL response assessment (Blood 2018), establishing standardized criteria for CR, PR, MRD, and progressive disease that are universally applied in international CLL clinical trials, regulatory submissions, and clinical practice, enabling cross-trial comparisons and harmonized evaluation of novel agents.

Representative Works 代表性著作

[1]

Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions (CLL11)

New England Journal of Medicine (2014)

Phase III CLL11 trial establishing obinutuzumab superiority over rituximab in combination with chlorambucil in previously untreated unfit CLL, leading to the first FDA approval of a new front-line CLL agent based on head-to-head superiority.

[2]

Frontline Chemoimmunotherapy with Fludarabine, Cyclophosphamide, and Rituximab versus Bendamustine and Rituximab in Patients with Advanced Chronic Lymphocytic Leukemia (CLL10)

Lancet Oncology (2016)

Phase III CLL10 trial comparing FCR versus BR in fit CLL patients, defining the age-dependent differential in efficacy and toxicity between regimens.

[3]

iwCLL guidelines for diagnosis, indications for treatment, response assessment and supportive management of CLL

Blood (2018)

Definitive iwCLL response criteria and management guidelines for CLL, universally adopted in clinical trials and regulatory submissions.

🏆Awards & Recognition 奖项与荣誉

🏆German CLL Study Group (GCLLSG) Deputy Head
🏆European Hematology Association (EHA) Scientific Committee Member
🏆iwCLL Guidelines Steering Committee
🏆Deutsche Krebshilfe (German Cancer Aid) Research Award

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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