PI(s): Mohamed Yassin

Contact:

yassinmoha@gmail.com Dr.a.shurafa@gmail.com AAlshurafa@hamad.qa

PI(s): Andrea Visentin

Short description:

This is an international retrospective, observational study aiming at assessing the effectiveness and safety of ibrutinib plus venetoclax treatment in patients with chronic lymphocytic leukemia in the real-world.

Objectives:

Primary objective:

• Describe the rate of discontinuation due to toxicity and treatment course completion of I+V fixed-duration therapy in patients with CLL in a real-world setting

Secondary objectives:

• Describe serious cardiovascular adverse events in patients with CLL treated with first line I + V
• Describe other serious adverse events that led to treatment discontinuation or death in patients with CLL treated with first line I + V
• Describe the stated reason for discontinuation or dose modification during I+V fixed-duration therapy
• Describe effectiveness of I + V (ORR, CR, rwPFS, TTNT and OS)

Contact:

eric-clldb.inab@certh.gr, andrea.visentin@unipd.it

PI(s): Blanca Espinet, Anna Puiggros, Panagiotis Baliakas

Short description:

Multicentric retrospective analysis on real-world evidence (RWE) or clinical trials data from patients included who underwent treatment with novel agents (BTK or BCL2 inhibitors).

Objectives:

• To assess the predictive relevance of complex karyotype in patients treated with targeted therapies:
• Impact of the number of cytogenetic aberrations for defining cytogenetic complexity: CK=3 or more vs High CK=5 or more
• Impact of the type of aberrations (i.e., structural vs numerical, balanced vs unbalanced)

Contact:

eric-clldb.inab@certh.gr bespinet@psmar.cat apuiggros@psmar.cat

PI(s): Andreas Agathangelidis, Thomas Chatzikonstantinou

Short description:

A real-world study assessing the clinical similarities of subsets #1, #2, and #8 and their corresponding satellites.

Objectives:

Primary objective:

• To obtain RWE regarding the TTFT, response to treatment, and TTNT of patients with CLL belonging to stereotyped subsets #1, #2, and #8 and their satellite subsets (#99, #169, #8B, respectively).

Secondary objective:

• To obtain RWE regarding the overall survival and the incidence of Richter transformation of patients with CLL belonging to stereotyped subsets #1, #2, and #8 and their satellite subsets (#99, #169, #8B, respectively).

Contact:

eric-clldb.inab@certh.gr, thomas.chatzikonstantinou@certh.gr

PI(s): Sunil Iyengar

Short description:

Retrospective study of outcomes in TP53 mutated and/or deleted CLL treated with chemotherapy-free frontline targeted therapies

Objectives:

Primary objective:

• To compare the Time to Next Treatment or Death (TTNT-D) of CLL patients with or without TP53 disruption (TP53 mutation or 17p13 deletion) receiving continuous targeted treatment in the frontline.

Secondary objectives:

• To compare the OS of CLL patients with or without TP53 disruption (TP53 mutation or 17p13 deletion) receiving continuous targeted treatment in the frontline.
• To compare the PFS and OS of CLL patients with or without TP53 disruption (TP53 mutation or 17p13 deletion) treated with different therapeutic modalities i.e., continuous v.s. fixed duration chemo-free regimens.
• To determine the impact of low-frequency TP53 variants in patients receiving chemo-free frontline treatment.
• To determine the impact of single or multiple TP53 defects.
• To determine the relevance of IGHV somatic hypermutation status within patients with TP53 disruption.

Contact:

eric-clldb.inab@certh.gr sunil.iyengar@rmh.nhs.uk

PI(s):Elzbieta Kalicinska

Short description:

This real-world study aims to compare the cumulative incidence of severe infections (G3-G5) in CLL patients treated with venetoclax-based regimens or second-generation BTKi.

Objectives:

Primary objectives:

• To compare the cumulative incidence for severe infections (G3-G5) in CLL patients treated with venetoclax-based regimens or second-generation BTKi in the first line.
• To compare the cumulative incidence for severe infections (G3-G5) in patients with R/R CLL treated in the second-line with venetoclax-based regimens or the new BTKi.

Secondary objectives:

• To compare the cumulative incidence of all infections between patients treated with venetoclax-based vs new BTKi.
• To assess the impact of infections on compliance, the timeliness of treatment administered, and the rate of discontinuation therapy.

Contact:

eric-clldb.inab@certh.gr elzbietakalicinska@gmail.com