Maintenance venetoclax plus subcutaneous cytarabine for fit adults with AML
Maintenance Venetoclax Based Therapy Post Complete Remission in AML Fit Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Sohag and 1 other locations) |
| Trial ID | NCT07244367 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sohag and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.