Patients Treated in Real Life With VEnetoclax for WAldens... | NCT06200220

Studies
Patients Treated in Real Life With VEnetoclax for WAldenström Macroglobulinemia

NCT06200220

Sponsor

Poitiers University Hospital

Status

Unknown status

Last Update Posted

Jan 10, 2024Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

Waldenstrom's Macroglobulinaemia Refractory

Interventions

Venetoclax

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 28, 2023Actual

Primary Completion Date

Dec 28, 2023Actual

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Dec 28, 2023

First Submission Date that Met QC Criteria

Dec 28, 2023

First Posted Date

Jan 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2023

Last Update Posted Date

Jan 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Name	Type	Description	Arm Group Labels	Other Names
Venetoclax	Drug	Observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficiency	ORR, MRR	2018 to 2025

Secondary Outcomes

Measure	Description	Time Frame
Tolerance	Adverse events	2018 to 2025
Efficiency in specific population	ORR in CXCR4 mutated patients, ORR in patients previously treated with BTK inhibitors

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Waldenstrom's macroglobulinemia
Treatment with Venetoclax
Non opposition

Exclusion Criteria: none

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients from university hospitals in France (16 center)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
cécile tomowiak, Dr	Contact	+33 (0)5.49.44.43.07		cecile.tomowiak@chu-poitiers.fr
Mathilde Vonfeld, Intern	Contact	+33 (0)5.49.44.43.07		mathilde.vonfeld@chu-poitiers.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Poitiers	Recruiting	Poitiers		86000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C579720	venetoclax

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided