REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy

Small Lymphocytic Leukemia Clinical Trial

— RESIST  

Official title:

REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621148
• Other study ID #: FILObsLLC_RESIST
• Status: Completed
• Start date: January 25, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Data evaluating and quantifying real-world outcomes of patients post-ibrutinib discontinuation, as well as outcomes of patients who have progressed on a Bruton tyrosine kinases inhibitors (BTKi) and received prior venetoclax are very limited. There are no robust studies specifically designed to assess outcomes of patients with chronic lymphocytic leukemia (CLL) receiving third line or subsequent treatments. As such, there is no established standard of care for these multiple Relapsed/Refractory (RR) patients. Furthermore, despite new oral agents approved in third-line RR CLL, there are limited published data on how to best sequence these agents and how to manage patients who fail these therapies. As the best salvage therapy in patients who fail all available oral these agents is unknown, this is a population of patients with unmet medical need.

The aim of this study is to determine unmet need and treatment patterns of data from two types of populations, all previously exposed to ibrutinib (or other BTKi) for the full patient population and both ibrutinib (or other BTKi and venetoclax) for the narrow patient population, where these agents failed these subcategories of patient populations, at least in 3rd line therapy (in other words, having at least received two lines of therapy before)

• Patients with prior treatment with BTKi (full patient population) - Underlying tenet:

these patients have been treated with a BTKi in at least one of two or more prior lines of therapy and progressed - FULL POPULATION

• Patients who progressed BTKi and failed VEN (defined as patients who discontinued venetoclax (VEN) due to disease progression, intolerability, or failure to achieve an objective response within 3 months of initiating therapy; small patient population) - Tenet: these patients have been treated with both BTKi and VEN in any one of the prior two lines of therapy and progressed. - NARROW POPULATION

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented diagnosis of CLL or small lymphocytic leukemia (SLL).

• = 18 years of age the time of initial diagnosis.

• Venetoclax therapy in at least third line of treatment (LOT) during the period considered, following at least one LOT with BTKi

• Patients who received VEN during prior LOTs are eligible.

• Patient not opposed to data collection (including deceased patients)

Exclusion Criteria:

• Exposure to cellular therapy, including CAR T-cells / Allo-Stem Cell Transplantation.

• Richter's transformation.

Related Conditions & MeSH terms

• CLL, Refractory
• CLL, Relapsed
• Leukemia, Lymphoid
• Small Lymphocytic Leukemia

Locations

Country	Name	City	State
France	CHU Estaing - Hématologie Clinique Adulte	Clermont-Ferrand
France	Centre Léon Bérard - Hématologie	Lyon
France	Institut Paoli-Calmettes - Hématologie Clinique	Marseille
France	MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique	Montpellier
France	Bordeaux Pessac	Pessac
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Strasbourg - Icans	Strasbourg
France	Toulouse - IUCT Oncopole - Service d'Hématologie	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation	Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of treatment patterns in patients with CLL	Overall response rate (complete, partial, stable) for each treatment received	from BTKi initiation until progression/failure at Venetoclax treatment, assessed up to 7 years