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

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

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

Study Overview

• Status: Suspended
• Conditions: Chronic Lymphocytic Leukemia (CLL)

• Study Type: Observational
• Enrollment (Estimated): 272

Contacts and Locations

• Study Contact: Name: Hilla Banayan; Email: hilla.banayan@abbvie.com

Study Locations

• Israel
  • Afula, Israel, 1834111
    • HaEmek Medical Center /ID# 210900
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 210320
  • Haifa, Israel, 3339419
    • Bnai Zion Medical Center /ID# 206963
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center /ID# 207896
  • Jerusalem, Israel, 91120
    • Hadassah /ID# 207898
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center /ID# 215466
  • Nahariya, Israel, 2210001
    • Galilee Medical Center /ID# 207899
  • Petakh Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 206961
  • Rehovot, Israel, 7661041
    • Kaplan Medical Center /ID# 207902
  • Safed, Israel, 13100
    • Ziv Medical Center /ID# 215462
  • HaDarom
    • Be'er Sheva, HaDarom, Israel, 8443901
      • Soroka University Medical Center /ID# 207897
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 207900
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 206962

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with diagnosed CLL and receiving venetoclax as per label.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with Chronic Lymphocytic Leukemia (CLL); Patients with diagnosed CLL and eligible to venetoclax as per label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; venetoclax; Chronic Lymphocytic Leukemia; observation
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia, B-Cell; Chronic Disease; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: P19-287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No