Post Marketing Observational Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice

AbbVie13 sites in 1 country272 target enrollmentFebruary 10, 2019

ConditionsChronic Lymphocytic Leukemia (CLL)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Lymphocytic Leukemia (CLL)
Sponsor: AbbVie
Enrollment: 272
Locations: 13
Primary Endpoint: Overall Response Rate (ORR)
Status: Suspended
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate effectiveness and safety in routine clinical practice in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).

Registry

clinicaltrials.gov

Start Date

February 10, 2019

End Date

February 28, 2027

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants with diagnosed Chronic Lymphocytic Leukemia (CLL) and eligible for venetoclax as per label.
•Participants for whom the physician has decided to initiate CLL treatment with venetoclax.
•Participants who have been informed verbally and in writing about this study, and who do not object to their data being processed or subjected to data quality control.

Exclusion Criteria

•Participants currently participating (or previously participated) in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Time Frame: Up to approximately 12 months

ORR to treatment is defined as the proportion of patients with complete response (CR), Complete Response with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR) and partial response (PR), according to physician's assessment.

Secondary Outcomes

Time to Response (TTR)(Up to approximately 24 months)
Overall Survival (OS)(Up to approximately 48 months)
Time To Progression (TTP)(Up to approximately 48 months)
Progression-Free Survival (PFS)(Up to approximately 48 months)
Time to Best Response to Treatment(Up to approximately 24 months)
PFS after Disease Progression Following Venetoclax Treatment(Up to approximately 48 months)
Overall Response Rate (ORR)(Up to approximately 24 months)
Complete Response (CR) Rate(Up to approximately 24 months)
Minimal Residual Disease(Up to approximately 24 months)
Change in Score of EuroQol 5 Dimensions (EQ-5D-5L)(Up to approximately 24 months)
Time To Next Treatment(Up to approximately 48 months)
Duration of Response (DOR)(Up to approximately 48 months)
Best Response under Next CLL Treatment(Up to approximately 48 months)