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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

— REVEAL  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03659669
• Other study ID #: P19-287
• Status: Suspended
• Start date: February 10, 2019
• Est. completion date: February 28, 2027

Study information

• Verified date: October 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 272
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Israel	HaEmek Medical Center /ID# 210900	Afula
Israel	Soroka University Medical Center /ID# 207897	Be'er Sheva	HaDarom
Israel	Bnai Zion Medical Center /ID# 206963	Haifa
Israel	Rambam Health Care Campus /ID# 210320	Haifa
Israel	Hadassah /ID# 207898	Jerusalem
Israel	Shaare Zedek Medical Center /ID# 207896	Jerusalem
Israel	Meir Medical Center /ID# 215466	Kfar Saba
Israel	Galilee Medical Center /ID# 207899	Nahariya
Israel	Rabin Medical Center /ID# 206961	Petakh Tikva
Israel	The Chaim Sheba Medical Center /ID# 207900	Ramat Gan	Tel-Aviv
Israel	Kaplan Medical Center /ID# 207902	Rehovot
Israel	Ziv Medical Center /ID# 215462	Safed
Israel	Tel Aviv Sourasky Medical Center /ID# 206962	Tel Aviv-Yafo	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	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.	Up to approximately 12 months
Secondary	Overall Response Rate (ORR)	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.	Up to approximately 24 months
Secondary	Complete Response (CR) Rate	CR is defined as the proportion of participants with either CR and CRi, according to physician's assessment.	Up to approximately 24 months
Secondary	Time to Response (TTR)	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.	Up to approximately 24 months
Secondary	Time to Best Response to Treatment	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.	Up to approximately 24 months
Secondary	Overall Survival (OS)	Overall survival (OS) is defined as the time from the date of first venetoclax intake to the date of death from any cause.	Up to approximately 48 months
Secondary	Time To Progression (TTP)	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.	Up to approximately 48 months
Secondary	Progression-Free Survival (PFS)	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.	Up to approximately 48 months
Secondary	Time To Next Treatment	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.	Up to approximately 48 months
Secondary	Duration of Response (DOR)	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.	Up to approximately 48 months
Secondary	PFS after Disease Progression Following Venetoclax Treatment	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.	Up to approximately 48 months
Secondary	Best Response under Next CLL Treatment	The best response under next CLL treatment is calculated in the sub-population of participants having a next CLL treatment after venetoclax discontinuation.	Up to approximately 48 months
Secondary	Minimal Residual Disease	The proportion of participants with assessment of the minimal residual disease under venetoclax treatment (assessed by flow cytometry or Polymerase Chain Reaction).	Up to approximately 24 months
Secondary	Change in Score of EuroQol 5 Dimensions (EQ-5D-5L)	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.	Up to approximately 24 months