RESIST: REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy

Sponsor
French Innovative Leukemia Organisation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05621148
Collaborator
Bristol-Myers Squibb (Industry)
120
8
6
15
2.5

Study Details

Study Description

Brief 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

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Full population

LLC patients with prior treatment with BTKi - 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

Narrow population

LLC Patients who progressed BTKi and failed VEN (defined as patients who discontinued 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

Outcome Measures

Primary Outcome Measures

  1. Response rate of treatment patterns in patients with CLL [from BTKi initiation until progression/failure at Venetoclax treatment, assessed up to 7 years]

    Overall response rate (complete, partial, stable) for each treatment received

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Estaing - Hématologie Clinique Adulte Clermont-Ferrand France 63000
2 Centre Léon Bérard - Hématologie Lyon France 69373
3 Institut Paoli-Calmettes - Hématologie Clinique Marseille France 13273
4 MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique Montpellier France 34295
5 Bordeaux Pessac Pessac France 33604
6 Centre Hospitalier Lyon Sud Pierre-Bénite France 69495
7 Strasbourg - Icans Strasbourg France 67033
8 Toulouse - IUCT Oncopole - Service d'Hématologie Toulouse France 31059

Sponsors and Collaborators

  • French Innovative Leukemia Organisation
  • Bristol-Myers Squibb

Investigators

  • Principal Investigator: Loïc YSEBAERT, French Innovative Leukemia Organisation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier:
NCT05621148
Other Study ID Numbers:
  • FILObsLLC_RESIST
First Posted:
Nov 17, 2022
Last Update Posted:
Nov 17, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2022