News – CLL-CLUE

CLL-CLUE presentations at the 63rd ASH Annual Meeting and Exposition

The 63rd ASH Annual Meeting and Exposition took place in Atlanta, USA, from December 10-14 2021. CLL-CLUE partners Barbara Eichhorst and Carsten U. Niemann gave oral presentations on two of the clinical trials included in CLL-CLUE.

Barbara Eichhorst presented the abstract “A Randomized Phase III Study of Venetoclax-Based Time-Limited Combination Treatments (RVe, GVe, GIVe) Vs Standard Chemoimmunotherapy (CIT: FCR/BR) in Frontline Chronic Lymphocytic Leukemia (CLL) of Fit Patients: First Co-Primary Endpoint Analysis of the International Intergroup GAIA (CLL13) Trial[SS1]”. This is the primary analysis of the phase III study GAIA/CLL13, which showed that time-limited therapies with obinutuzumab/venetoclax and obinutuzumab /venetoclax /ibrutinib provided superior undetectable minimal residual disease (uMRD) rates in peripheral blood at month 15 compared to chemoimmunotherapy. The uMRD rates in bone marrow, and complete response rates (CRR), were also higher in the arms with targeted therapies than in the chemoimmunotherapy arm. All treatment arms showed a good safety profile in this fit patient population.

Carsten U. Niemann presented the abstract “Time-Limited Venetoclax and Ibrutinib for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (R/R CLL) Who Have Undetectable MRD – Primary Analysis from the Randomized Phase II Vision HO141 Trial[SS2]”. This is the primary analysis of the phase II VISION/HO141 trial, which showed that minimal residual disease (MRD) guided time-limited treatment with ibrutinib and venetoclax in the setting of relapsed/refractory chronic lymphocytic leukemia (CLL) is feasible. No patients progressed after treatment cessation while patients becoming MRD positive successfully reinitiated therapy. A favorable benefit-risk profile was demonstrated, with no new safety signals.

Panel discussion about Artificial Intelligence tools for personalized medicine from the perspective of financing and clinical practice at NCPHM from Poiana Brașov, Romania

An excellent panel discussion took place at the 8th edition of the National Conference on Pharmacoeconomics and Health Management (www.cnfms.ro), held on 14-16th of October 2021 at Poiana Brașov, Romania, with invited members of the CLL-CLUE consortium, international experts and representatives of payer organizations:

Sigrid S. SKANLAND, PhD – Oslo University Hospital, Norway
Carsten Utoft NIEMANN, MD, PhD, Associate Professor – Rigshospitalet, Copenhagen University Hospital, Denmark
Adrian GHEORGHE, expert, former President of NHIH, Romania
Prof. Pharm. Dr. Tomas TESAR, Slovakia
Prof. Zoltan KALÓ, Syreon Research Institute, Hungary
László LORENZOVICI, MD, Syreon Research Romania

The theme of this discussion was “Artificial Intelligence tools for personalized medicine from the perspective of financing and clinical practice in onco-hematology”, with a focus on the CLL-CLUE project.
During the panel discussion the following questions were debated:
• How to integrate an AI assisted tool into the clinical therapeutic protocols? How to change the practice of defining such protocols for AI assisted tools?
• How to set financial protocols in concordance to the AI assisted tool? How to handle situations where financial constraints and optimal therapies are in conflict?
• How to integrate the reimbursement of genetic / other specific tests required for the decision-making algorithm to the health care financing systems?
• What are the most important differences in the implementation of AI assisted tools between Western and Eastern European countries?

June 2021: CLL-CLUE patient representative meeting

It was our pleasure and honor to have the first meeting with our two patient representatives on the 21st of June 2021 to discuss how to improve communication with patients, how to meet their expectations on use of data and biobank samples to improve treatment outcome, and how to support their participation in future clinical trials.

The role of patient representatives
The role of the patient representative is to ensure that the views of patients, caregivers and families are taken into consideration when planning/developing services. This will help facilitate the “patient voice” being heard throughout the wider organization, whenever decisions that affect healthcare are made.

The CLL-CLUE patient representatives
The CLL-CLUE project has two patient representatives. The first representative has more than 10 years of experience with the role, and finds it more and more meaningful. She emphasized the importance of using lay language that the patient can understand when informing about research projects and clinical trials. “The better the patient understands the study, the easier it will be for the patient to give informed consent”, she said. The second patient representative agreed with this. He also pointed to the role of the physician as a guide to help the patient navigate in shared decision-making. The aim of CLL-CLUE is to implement precision medicine for CLL patients. Establishing a dialogue with the patients about their needs and concerns ensures that this aim remains in focus.

Please find details about CLL-CLUE project on page 4

January 2021: The official newsletter (no. 5 / 2021) of the ERAPerMed published the Results of the Joint Transnational Call 2020.

This work is supported by a grant of:

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The Research Council of Norway (RCN)	Academy of Finland, (AKA)	German Federal Ministry of Education and Research (BMBF)	Innovation Fond Denmark, IFD	Romanian National Authority for Scientific Research and Innovation, CCDI – UEFISCDI, project number ERANET-PERMED-CLL-CLUE 196, within PNCDI III