NCT06993883

Brief Summary

retrospective observational study to evaluate the benefit of adding venetoclax to chemotherapy in the first or second line setting in Sohag governorate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

May 13, 2025

Last Update Submit

May 27, 2025

Conditions

AML (Acute Myelogenous Leukemia)

Keywords

AMLvenetoclaxSohagEgypt

Outcome Measures

Primary Outcomes (1)

  • response rate

    through the study completion an average 1.5 years

Secondary Outcomes (1)

  • overall survival

    1.5 years

Study Arms (3)

1st line

newly diagnosed AML patients unfit for aggressive chemotherapy who received reduced intensity protocols plus venetoclax in the 1st line setting.

Drug: Venetoclax

2nd line

refractory recurrent AML patients after 1st line chemotherapy who received venetoclax plus 2nd line chemotherapy.

Drug: Venetoclax

3rd line

refractory recurrent AML patients after 2 lines chemotherapy who received venetoclax plus 3rd line chemotherapy.

Drug: Venetoclax

Interventions

VenetoclaxDRUG

observational study for the result of venetoclax use combined with chemotherapy in AML patients in Sohag governorate

1st line2nd line3rd line

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

observational descriptive study

You may qualify if:

  • Patients aged between 18 and 80 years.
  • Pathological confirmation of AML.
  • Use of venetoclax plus chemotherapy as a 1st versus 2nd line treatment.

You may not qualify if:

  • age \< 18 years age \> 80 years other types of acute leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Select, 82524, Egypt

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of clinical oncology and hemato oncology

Study Record Dates

First Submitted

May 13, 2025

First Posted

May 29, 2025

Study Start

March 1, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations

EG(1)