Acute Myeloid Leukaemia (AML)NCT07244367
Maintenance Venetoclax in AML Fit Patients
A study testing SC cytarabine +Venetoclax in people with Acute Myeloid Leukaemia (AML), run by Sohag University at 2 sites in Egypt.
Trial summary
this study will explore the efficacy of maintenance SC cytarabine + venetoclax therapy as regard disease free survival (DFS) in AML fit patients who achieved CR after highly aggressive chemotherapy as bridge for BMT or if BMT will be delayed or canceled due to any other reason. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukaemia (AML)
- What is being tested?
- SC cytarabine +Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 .
Who cannot join
- Patients not on CR . Age : younger than 18 or older than 60 . Patients not eligible for bone marrow transplation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Walaa G Mohamed, Lecturer contact
Egypt2 sites, 2 recruiting
- Recruiting
Sohag university hospital
Sohag
Eman I Abdelshakour, Asst lect, +201063901450 ext. +201122103385, Eman011065@med.sohag.edu.eg
- Recruiting
Sohag university
Sohag
Eman I Abdelshakour, Asst lect, +201063901450 ext. +201122103385, Eman011065@med.sohag.edu.eg
About this study
Official title: Maintenance Venetoclax Based Therapy Post Complete Remission in AML Fit Patients
this study will explore the efficacy of maintenance SC cytarabine + venetoclax therapy as regard disease free survival (DFS) in AML fit patients who achieved CR after highly aggressive chemotherapy as bridge for BMT or if BMT will be delayed or canceled due to any other reason.
Read the detailed description
this study is a prospective,phase III , randomized ,open , interventional study include young fit patients who will receive maintenance venetoclax +subcutaneous cytarabine as bridge for BMT or if BMT will be delayed
- Conditions
- Acute Myeloid Leukaemia (AML)
- Being tested
- SC cytarabine +Venetoclax
- Keywords
- AML, Venetoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC cytarabine +VenetoclaxDrug
Also called Venclexta
SC Cytarabine (20 mg) administrated on days 1-7 ,,Venetoclax (100 mg ) administrated on days 1-7,,Voriconazole 200 mg 1x2 administrated on days , Best supportive care as needed . Up to 12 cycles or until patients undergo bone marrow transplantation
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | will receive SC cytarabine + venetoclax till bone marrow transplantation or for 12 cycles for patient will not undergo BMT , SC Cytarabine (20 mg) administrated on days 1-7 , Venetoclax (100 mg ) administrated on days 1-7 , Voriconazole 200 mg 1x2 administrated on days 1-7 + best supportive care BSC Receives: Drug: SC cytarabine +Venetoclax |
| Arm B | No intervention | Patients Will receive Best supportive care( BSC )only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival DFS
time from complet remission to relapse or death from any cause in AML fit patients receiving maintenance SC cytarabine plus venetoclax after intensive chemotherapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukaemia (AML)Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- this study is a prospective,phase III , randomized ,open , interventional study. double blind, placebo control clinical trial . Evaluating efficacy of maintenance venetoclax based therapy in Acute meyloid leukemia fit patients who acheived complete remission after standard induction and consolidation therapy.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ibrahim Abdelshakour, Sohag University
- Investigators
- Elsayed M Ali, Professor, Study director, Faculty of medicine sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244367
- Sponsor's protocol ID
- Soh-Med-25-9---3MD
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Papaemmanuil E, Gerstung M, Bullinger L, Gaidzik VI, Paschka P, Roberts ND, et al. Genomic classification and prognosis in acute myeloid leukemia. N Engl J Med. 2016;374:2209-21. 2. DiNardo CD, Erba HP, Freeman SD, Wei AH. Acute myeloid leukaemia. Lancet. 2023;401:2073-86. 3. Miranda-Filho A, Piñeros M, Ferlay J, et al: Epidemiological patterns of leukaemia in 184 countries: A population-based study. Lancet Haematol 5:e14-e24, 2018
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Venetoclax Based Therapy Post Complete Remission in AML Fit Patients
- ClinicalTrials.gov ID
- NCT07244367
- Acronym / sponsor ID
- Soh-Med-25-9---3MD
- Conditions
- Acute Myeloid Leukaemia (AML)
- Keywords
- AML, Venetoclax
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study will explore the efficacy of maintenance SC cytarabine + venetoclax therapy as regard disease free survival (DFS) in AML fit patients who achieved CR after highly aggressive chemotherapy as bridge for BMT or if BMT will be delayed or canceled due to any other reason.
Detailed description
this study is a prospective,phase III , randomized ,open , interventional study include young fit patients who will receive maintenance venetoclax +subcutaneous cytarabine as bridge for BMT or if BMT will be delayed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- this study is a prospective,phase III , randomized ,open , interventional study. double blind, placebo control clinical trial . Evaluating efficacy of maintenance venetoclax based therapy in Acute meyloid leukemia fit patients who acheived complete remission after standard induction and consolidation therapy.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: SC cytarabine +Venetoclaxwill receive SC cytarabine + venetoclax till bone marrow transplantation or for 12 cycles for patient will not undergo BMT , SC Cytarabine (20 mg) administrated on days 1-7 , Venetoclax (100 mg ) administrated on days 1-7 , Voriconazole 200 mg 1x2 administrated on days 1-7 + best supportive care BSC |
| Arm B | No intervention | –Patients Will receive Best supportive care( BSC )only |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (1 listed)
- Patients not on CR . Age : younger than 18 or older than 60 . Patients not eligible for bone marrow transplation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC cytarabine +VenetoclaxAlso: VenclextaSC Cytarabine (20 mg) administrated on days 1-7 ,,Venetoclax (100 mg ) administrated on days 1-7,,Voriconazole 200 mg 1x2 administrated on days , Best supportive care as needed . Up to 12 cycles or until patients undergo bone marrow transplantation | Drug | Arm A |
Primary outcome
Disease free survival DFS
Time frame: 24 months
time from complet remission to relapse or death from any cause in AML fit patients receiving maintenance SC cytarabine plus venetoclax after intensive chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Results publication1. Papaemmanuil E, Gerstung M, Bullinger L, Gaidzik VI, Paschka P, Roberts ND, et al. Genomic classification and prognosis in acute myeloid leukemia. N Engl J Med. 2016;374:2209-21. 2. DiNardo CD, Erba HP, Freeman SD, Wei AH. Acute myeloid leukaemia. Lancet. 2023;401:2073-86. 3. Miranda-Filho A, Piñeros M, Ferlay J, et al: Epidemiological patterns of leukaemia in 184 countries: A population-based study. Lancet Haematol 5:e14-e24, 2018
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Walaa G Mohamed, Lecturer contact
Elsayed M Ali, Professor study director
Faculty of medicine sohag university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SC cytarabine +Venetoclax in people with Acute Myeloid Leukaemia (AML), run by Sohag University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman I Abdelshakour, Asst lect (+201063901450 ext. +201122103385, Eman011065@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival DFS (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07244367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.