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Patients Treated in Real Life With VEnetoclax for WAldenström Macroglobulinemia

NCT06200220 — Unknown, 45 participants, Poitiers University Hospital

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RegistryNCT06200220
StatusUnknown
Study typeObservational
Enrollment45 (Estimated)
SponsorPoitiers University Hospital (Other)
ConditionsWaldenstrom's Macroglobulinaemia Refractory
InterventionsVenetoclax (Drug)
Datesstart 2023-12-28, primary completion 2023-12-28, completion 2025-12-01 (estimated), first posted 2024-01-10, last updated 2024-01-10
Locations1 site in France

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-Summary

Waldenström macroglobulinemia (WM) is an incurable disease. BCL2 antagonist, an important anti-apoptosys molecule, is already approved for the treatment of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia. Recently, a clinical trial including 32 patients with WM treated with Venetoclax showed an overall response rates of 84% and a major response rate of 81%. However, there is no in real life data, in the french population, of the efficiency of Venetoclax in WM. The aim of our multicentric retrospective study is to evaluate the efficiency and tolerance of Venetoclax in WM.

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+Arms and interventions

  • Venetoclax (Drug): Observational study

+Outcome measures

Primary outcomes

  • Efficiency [2018 to 2025]: ORR, MRR

Secondary outcomes

  • Tolerance [2018 to 2025]: Adverse events
  • Efficiency in specific population [2018 to 2025]: ORR in CXCR4 mutated patients, ORR in patients previously treated with BTK inhibitors

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Waldenstrom's macroglobulinemia
* Treatment with Venetoclax
* Non opposition

Exclusion Criteria: none

+Locations (1)

FacilityCityCountryStatus
CHU PoitiersPoitiersFranceRecruiting

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