Clinical trial NCT03659669: A Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice
Official title: Post Marketing Observational Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: Chronic Lymphocytic Leukemia
Cancer
venetoclax
observation
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-09-06
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with diagnosed CLL and receiving venetoclax as per label.

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


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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 24 months
measure: Complete Response (CR) Rate
timeFrame: Up to approximately 24 months
measure: Time to Response (TTR)
timeFrame: Up to approximately 24 months
measure: Time to Best Response to Treatment
timeFrame: Up to approximately 24 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 48 months
measure: Time To Progression (TTP)
timeFrame: Up to approximately 48 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 48 months
measure: Time To Next Treatment
timeFrame: Up to approximately 48 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 48 months
measure: PFS after Disease Progression Following Venetoclax Treatment
timeFrame: Up to approximately 48 months
measure: Best Response under Next CLL Treatment
timeFrame: Up to approximately 48 months
measure: Minimal Residual Disease
timeFrame: Up to approximately 24 months
measure: Change in Score of EuroQol 5 Dimensions (EQ-5D-5L)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 207897
state: HaDarom
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 207900
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 206962
state: Tel-Aviv
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 210900
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 210320
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 206963
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 207896
city: Jerusalem
country: Israel
facility: Hadassah /ID# 207898
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 215466
city: Nahariya
country: Israel
facility: Galilee Medical Center /ID# 207899
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 206961
city: Rehovot
country: Israel
facility: Kaplan Medical Center /ID# 207902
city: Safed
country: Israel
facility: Ziv Medical Center /ID# 215462
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: