Clinical trial Recruiting at 2 sites Interventional Ages 18 to 60

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.

More Acute Myeloid Leukemia (AML) trials

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment80 (estimated)
SponsorSohag University
Academic / other
Drugs / interventionschemotherapy
Locations2 sites (Sohag and 1 other locations)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedSeptember 1, 2026
Study endsSeptember 1, 2027
Registry record updatedNovember 24, 2025
Trial IDNCT07244367 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.