REVEAL: A Study to Describe the Effectiveness and Safety of Venetoclax Treatment in Chronic Lymphocytic Leukemia (CLL) Patients in Routine Clinical Practice

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03659669

Collaborator

(none)

205

Enrollment

Locations

96.6

Anticipated Duration (Months)

15.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia (CLL)

Study Design

Study Type:

Observational

Anticipated Enrollment :

205 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 10, 2019

Anticipated Primary Completion Date :

Feb 28, 2027

Anticipated Study Completion Date :

Feb 28, 2027

Arms and Interventions

Arm	Intervention/Treatment
Patients with Chronic Lymphocytic Leukemia (CLL) Patients with diagnosed CLL and eligible to venetoclax as per label.

Outcome Measures

Primary Outcome Measures

Overall Response Rate (ORR) [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 Outcome Measures

Overall Response Rate (ORR) [Up to approximately 24 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) or partial response (PR), according to physician's assessment.
Complete Response (CR) Rate [Up to approximately 24 months]
CR is defined as the proportion of participants with either CR and CRi, according to physician's assessment.
Time to Response (TTR) [Up to approximately 24 months]
TTR is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented the response among complete response, complete response with incomplete bone marrow recovery, nodular partial response, and partial response.
Time to Best Response to Treatment [Up to approximately 24 months]
The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the assessment having documented the best response among CR, CRi, nPR, and PR.
Overall Survival (OS) [Up to approximately 48 months]
Overall survival (OS) is defined as the time from the date of first venetoclax intake to the date of death from any cause.
Time To Progression (TTP) [Up to approximately 48 months]
The Time To Progression (TTP) is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression.
Progression-Free Survival (PFS) [Up to approximately 48 months]
PFS is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression or death from any cause.
Time To Next Treatment [Up to approximately 48 months]
Time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation.
Duration of Response (DOR) [Up to approximately 48 months]
DOR is calculated in the sub-population of patients experiencing treatment response (complete response, complete response with incomplete bone marrow recovery, nodular partial response or partial response) from the date when response is first met to the date of first following documented progression.
PFS after Disease Progression Following Venetoclax Treatment [Up to approximately 48 months]
PFS following venetoclax treatment is defined as the time from the date of first next CLL treatment intake to the date of the following documented progression or death from any cause.
Best Response under Next CLL Treatment [Up to approximately 48 months]
The best response under next CLL treatment is calculated in the sub-population of participants having a next CLL treatment after venetoclax discontinuation.
Minimal Residual Disease [Up to approximately 24 months]
The proportion of participants with assessment of the minimal residual disease under venetoclax treatment (assessed by flow cytometry or Polymerase Chain Reaction).
Change in Score of EuroQol 5 Dimensions (EQ-5D-5L) [Up to approximately 24 months]
The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The scores for the 5 dimensions are used to compute a single utility index score ranging from zero (0.0) to 1 (1.0) representing the general health status of the individual. The EQ-5D-5L also contains a visual analog scale (VAS) to assess the subject's overall health.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soroka University Medical Center /ID# 207897	Be'er Sheva	HaDarom	Israel	8443901
2	The Chaim Sheba Medical Center /ID# 207900	Ramat Gan	Tel-Aviv	Israel	5265601
3	HaEmek Medical Center /ID# 210900	Afula		Israel	1834111
4	Rambam Health Care Campus /ID# 210320	Haifa		Israel	3109601
5	Bnai Zion Medical Center /ID# 206963	Haifa		Israel	3339419
6	Shaare Zedek Medical Center /ID# 207896	Jerusalem		Israel	91031
7	Hadassah /ID# 207898	Jerusalem		Israel	91120
8	Meir Medical Center /ID# 215466	Kfar Saba		Israel	4428164
9	Galilee Medical Center /ID# 207899	Nahariya		Israel	2210001
10	Rabin Medical Center /ID# 206961	Petakh Tikva		Israel	4941492
11	Kaplan Medical Center /ID# 207902	Rehovot		Israel	7661041
12	Ziv Medical Center /ID# 215462	Safed		Israel	13100
13	Tel Aviv Medical Center /ID# 206962	Tel Aviv		Israel	64239