Maintenance venetoclax plus subcutaneous cytarabine for fit adults with AML
Official title: Maintenance Venetoclax Based Therapy Post Complete Remission in AML Fit Patients
Run by Sohag University · NCT07244367 · Data updated 2026-11-12
This trial will test whether maintenance venetoclax combined with subcutaneous cytarabine helps keep remission longer in fit adults (18–60) with AML who achieved complete remission but cannot get a bone marrow transplant right away.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Sohag University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Sohag and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2027 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT07244367 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Fit adults aged 18–60 with AML who have achieved complete remission after first- or second-line chemotherapy and who are not eligible for immediate bone marrow transplantation are ideal candidates.
✕Probably not a fit
Patients who are not in complete remission, those younger than 18 or older than 60, those eligible for immediate transplantation, or those with contraindications to venetoclax or cytarabine are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized, open-label phase III study enrolls fit adults aged 18–60 with acute myeloid leukemia who achieved complete remission after first- or second-line chemotherapy but are not eligible for immediate bone marrow transplantation. Participants receive maintenance venetoclax together with subcutaneous cytarabine as a bridge to transplant or when transplantation is delayed or cancelled. The primary outcome is disease-free survival, with follow-up for relapse and safety endpoints. The trial is conducted at Sohag University sites in Sohag, Egypt.
Why it matters
Potential benefit: If successful, this regimen could prolong disease-free survival and reduce early relapse while allowing safer postponement or preparation for transplantation.
How similar studies have gone: Venetoclax combinations have shown promising activity in AML, especially in older or unfit patients, but randomized phase III evidence for this specific maintenance approach with subcutaneous cytarabine is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age : 18 - 60 years . Patients who are not eligible for immediate bone marrow transplantation. Newly diagnosed AML patients who attained CR after 1st line. Refractory / recurrant AML patients who attained CR after 2nd line . Exclusion Criteria: * Patients not on CR . Age : younger than 18 or older than 60 . Patients not eligible for bone marrow transplation
Where it's running
-
Sohag university hospital
Sohag, Egypt Recruiting -
Sohag university
Sohag, Egypt Recruiting
Study contacts
- Study coordinator: Eman I Abdelshakour, Asst lect
- Email: Eman011065@med.sohag.edu.eg
- Phone: +201063901450
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.