NCT03659669

Brief Summary

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

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Feb 2019Feb 2027

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 10, 2019

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

8.1 years

First QC Date

September 4, 2018

Last Update Submit

October 19, 2023

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

Chronic Lymphocytic LeukemiaCancervenetoclaxobservation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Overall Response Rate (ORR)

    Up to approximately 24 months

  • Complete Response (CR) Rate

    Up to approximately 24 months

  • Time to Response (TTR)

    Up to approximately 24 months

  • Time to Best Response to Treatment

    Up to approximately 24 months

  • Overall Survival (OS)

    Up to approximately 48 months

  • +8 more secondary outcomes

Study Arms (1)

Patients with Chronic Lymphocytic Leukemia (CLL)

Patients with diagnosed CLL and eligible to venetoclax as per label.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with diagnosed CLL and receiving venetoclax as per label.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Soroka University Medical Center /ID# 207897

Beersheba, Southern District, 8443901, Israel

Location

The Chaim Sheba Medical Center /ID# 207900

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 206962

Tel Aviv, Tel Aviv, 6423906, Israel

Location

HaEmek Medical Center /ID# 210900

Afula, 1834111, Israel

Location

Rambam Health Care Campus /ID# 210320

Haifa, 3109601, Israel

Location

Bnai Zion Medical Center /ID# 206963

Haifa, 3339419, Israel

Location

Shaare Zedek Medical Center /ID# 207896

Jerusalem, 91031, Israel

Location

Hadassah /ID# 207898

Jerusalem, 91120, Israel

Location

Meir Medical Center /ID# 215466

Kfar Saba, 4428164, Israel

Location

Galilee Medical Center /ID# 207899

Nahariya, 2210001, Israel

Location

Rabin Medical Center /ID# 206961

Petah Tikva, 4941492, Israel

Location

Kaplan Medical Center /ID# 207902

Rehovot, 7661041, Israel

Location

Ziv Medical Center /ID# 215462

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellNeoplasms

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

February 10, 2019

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

IL(13)