NCT03987958

Brief Summary

This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Aug 2019Jul 2027

First Submitted

Initial submission to the registry

June 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

7.9 years

First QC Date

June 14, 2019

Last Update Submit

January 15, 2026

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, Venetoclax

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall survival is defined as the time from the date of first treatment to the date of death from any cause.

    Time from treatment to death from any cause, up to approximately 30 months

Secondary Outcomes (6)

  • Percentage of participants achieving composite complete remission (CR or CRi)

    Approximately 30 months

  • Time to transfusion independence

    Up to 30 months

  • Percentage of participants achieving transfusion independence

    Up to 30 months

  • Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics

    Up to approximately 30 months

  • Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30)

    Week 0 to approximately 30 months

  • +1 more secondary outcomes

Study Arms (1)

Venetoclax

Participants in this observational study will receive treatment with venetoclax for AML. The decision to treat with venetoclax has been made independently from this observational study before participants are offered the opportunity to participate in this study.

Eligibility Criteria

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

Participants with AML treated with venetoclax in routine clinical practice

You may qualify if:

  • Participant diagnosed with Acute Myeloid Leukemia (AML) and is eligible to receive venetoclax per Israel Ministry of Health.
  • Participant who will be treated with venetoclax and the decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.

You may not qualify if:

  • \- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Meir Medical Center /ID# 213352

Kfar Saba, Central District, 4428164, Israel

Location

Assuta Tel Aviv Medical Center /ID# 213371

Tel Aviv, Central District, 6971028, Israel

Location

HaEmek Medical Center /ID# 213370

Afula, Haifa District, 1834111, Israel

Location

Shaare Zedek Medical Center /ID# 228016

Jerusalem, Jerusalem, 91031, Israel

Location

Hadassah /ID# 213356

Jerusalem, Jerusalem, 91120, Israel

Location

ZIV Medical Center /ID# 229211

Safed, Northern District, 13100, Israel

Location

Soroka University Medical Center /ID# 213369

Beersheba, Southern District, 8443901, Israel

Location

The Chaim Sheba Medical Center /ID# 213353

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 213354

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rambam Health Care Campus /ID# 213355

Haifa, 3109601, Israel

Location

Bnai Zion Medical Center /ID# 213344

Haifa, 3339419, Israel

Location

Rabin Medical Center. /ID# 213343

Petah Tikva, 4941492, Israel

Location

Related Publications (1)

  • Wolach O, Levi I, Nachmias B, Tavor S, Amitai I, Ofran Y, Ganzel C, Zuckerman T, Okasha D, Hellmann I, Tadmor T, Dally N, Canaani J, Stemer G, Grunspan M, Berger AJ, Frankel N, Berelovich J, Bleterman A, Barak M, Cohen R, Moshe Y. Trial eligibility, treatment patterns, and outcome for venetoclax-based therapy in AML: a prospective cohort study. Blood Adv. 2025 Apr 8;9(7):1544-1554. doi: 10.1182/bloodadvances.2024014014.

    PMID: 39637307DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

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

June 14, 2019

First Posted

June 17, 2019

Study Start

August 8, 2019

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

IL(12)