Use of Venetoclax , AML , Sohag , Egypt (AML)

Use of Venetoclax in AML Patients Retrospective Experience in Sohag Governorate , an Area of Limited Resources in Upper Egypt

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

Study Overview

• Status: Completed
• Conditions: AML (Acute Myelogenous Leukemia)
• Intervention / Treatment: Drug: Venetoclax

Detailed Description

Acute Myeloid Leukaemia (AML) is an aggressive and most common hematologic malignancy in adults with a higher incidence in older adults with a median age of diagnosis of 68 years. It accounts for the largest number of annual deaths from leukaemia. Several new therapies have been approved after many years and are expected to impact patient outcomes, especially in patients aged 60 and above.

The standard treatment strategy for newly diagnosed AML is an intensive curative chemotherapy, and a combination of cytarabine (AraC) and anthracycline is recommended as remission induction therapy. However, many AML patients are ineligible for intensive therapy because of advanced age or co-morbidities. Treatment options are limited for these patients, especially older patients, who account for a large proportion of patients with newly diagnosed AML Venetoclax is an orally available, small-molecule selective B cell leukemia/lymphoma-2 ( BCL-2 ) inhibitor. In two placebo-controlled Phase 3 trials, the safety and efficacy of venetoclax-based therapy were confirmed in treatment-naive patients with AML who were ineligible for intensive chemotherapy owing to advanced age or comorbidities. In the VIALE-A study, the venetoclax plus azacitidine (AZA) arm demonstrated significantly better outcomes compared with the placebo plus AZA arm. In the VIALE-C study, the venetoclax plus LDAC arm did not meet its primary endpoint of a statistically significant improvement in overall survival compared with the placebo plus LDAC arm In November 2018, the US Food and Drug Administration granted accelerated approval for venetoclax in combination with AZA, decitabine or LDAC for the treatment of newly diagnosed AML in adults aged ≥75 years or who have co-morbidities that preclude the use of intensive induction chemotherapy.

Primary refractory disease and relapse remain the main obstacles for cure in AML. In fit patients several options based on higher doses of cytarabine have been published, with complete remission (CR) rates ranging from 40-55%. The BCL2 inhibitor venetoclax has demonstrated impressive antileukemic activity when combined with hypomethylating agents or low-dose cytarabine in newly diagnosed unfit AML patients, the addition of venetoclax to aggressive chemotherapy protocols as a second line in patients with refractory/ relapsed AML patients who are fit for such treatment gives marked advance in treating such difficult situation.

Even in some patients who show great side effects while using first line aggressive treatment , second line use of venetoclax combined with hypomethylating agents as a lower intensity second line option could give a great advance and safe method as a bridge to bone marrow transplantation and cure.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Egypt
  • Select
    • Sohag, Select, Egypt, 82524
      • Sohag faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

observational descriptive study

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1st line; newly diagnosed AML patients unfit for aggressive chemotherapy who received reduced intensity protocols plus venetoclax in the 1st line setting.	Drug: Venetoclax; observational study for the result of venetoclax use combined with chemotherapy in AML patients in Sohag governorate
2nd line; refractory recurrent AML patients after 1st line chemotherapy who received venetoclax plus 2nd line chemotherapy.	Drug: Venetoclax; observational study for the result of venetoclax use combined with chemotherapy in AML patients in Sohag governorate
3rd line; refractory recurrent AML patients after 2 lines chemotherapy who received venetoclax plus 3rd line chemotherapy.	Drug: Venetoclax; observational study for the result of venetoclax use combined with chemotherapy in AML patients in Sohag governorate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
response rate	through the study completion an average 1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	survival from diagnosis till study end or death	1.5 years

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: May 13, 2025
• First Submitted That Met QC Criteria: May 27, 2025
• First Posted (Actual): May 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: AML; venetoclax; Egypt; Sohag
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Antineoplastic Agents; Venetoclax
• Other Study ID Numbers: Soh-Med-25-4-11PD

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