Acute Myeloid LeukemiaPhase 4NCT07773909
Venetoclax With Hypomethylating Agents in Newly Diagnosed AML Unfit for Intensive Chemotherapy
A Phase 4 study testing Venetoclax, Azacitidine and Decitabine in people with Acute Myeloid Leukemia, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
This single-arm interventional study evaluated the short-term outcome of one 28-day cycle of venetoclax combined with a hypomethylating agent (azacitidine or decitabine) in adults with newly diagnosed acute myeloid leukemia who could not receive intensive induction chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venetoclax, Azacitidine and Decitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2022to 1 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed acute myeloid leukemia
- Age 18 years or older
- Deemed ineligible for intensive chemotherapy by the treating physician based on age (≥60 years), performance status or comorbidity, financial constraints, or patient unwillingness to receive intensive chemotherapy
- Written informed consent
Who cannot join
- Acute promyelocytic leukemia
- Previous treatment with a hypomethylating agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-Term Outcome of Newly Diagnosed Acute Myeloid Leukemia Treated With Hypomethylating Agents and Venetoclax in Patients Ineligible for Intensive Chemotherapy: A Single-Centre Prospective Study
This single-arm interventional study evaluated the short-term outcome of one 28-day cycle of venetoclax combined with a hypomethylating agent (azacitidine or decitabine) in adults with newly diagnosed acute myeloid leukemia who could not receive intensive induction chemotherapy. Twenty-four patients were enrolled at the Department of Haematology, Dhaka Medical College Hospital, Dhaka, Bangladesh. In addition to older and comorbid patients, the cohort included younger patients for whom intensive chemotherapy was financially inaccessible - a population under-represented in existing trial and registry data. The primary endpoint was the composite remission rate (complete remission plus complete remission with incomplete haematologic recovery) assessed by bone marrow examination on Day 28. Secondary endpoints included change in complete blood count parameters, treatment-emergent adverse events, and 28-day mortality.
Read the detailed description
Background and Rationale
Acute myeloid leukemia (AML) predominantly affects older adults, who often cannot tolerate intensive induction chemotherapy due to comorbidity or poor performance status. In low- and middle-income countries like Bangladesh, a secondary population-younger, medically fit patients-is also unable to receive intensive therapy due to prohibitive costs. While hypomethylating agents (HMAs) combined with venetoclax represent a standard lower-intensity approach, real-world data on this regimen are lacking in Bangladesh and sparse for financially constrained younger cohorts. This study evaluates the short-term outcomes of a single cycle of venetoclax plus an HMA in both groups at a public tertiary care hospital.
Intervention Details \& Dosing Nuances
Participants receive one 28-day cycle consisting of either IV azacitidine (75 mg/m² daily on Days 1-7) or IV decitabine (20 mg/m² daily on Days 1-5), based on physician discretion. Oral venetoclax is administered at 100 mg on Day 1, 200 mg on Day 2, and maintained at 100 mg daily from Day 3 to Day 28. The venetoclax dose is intentionally capped at 100 mg daily (instead of standard higher dosing) because all participants receive concomitant oral voriconazole (200 mg twice daily, Days 3-28) for antifungal prophylaxis, a strong CYP3A4 inhibitor requiring mandatory venetoclax dose reduction. Tumour lysis syndrome prophylaxis and standard supportive care (transfusions, antimicrobials) are provided per institutional protocols.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venetoclax, Azacitidine, Decitabine, Voriconazole
- 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.
VenetoclaxDrug
Oral venetoclax 100 mg on Day 1, 200 mg on Day 2, then 100 mg daily Days 3-28. Dose maintained at 100 mg from Day 3 because of concomitant strong CYP3A4 inhibition by voriconazole.
AzacitidineDrug
75 mg/m² intravenously, Days 1-7 of the 28-day cycle.
DecitabineDrug
20 mg/m² intravenously, Days 1-5 of the 28-day cycle.
VoriconazoleDrug
200 mg orally twice daily, Days 3-28, as antifungal prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax + Hypomethylating Agent | Experimental | Single arm. All participants received one 28-day cycle of venetoclax combined with either azacitidine or decitabine at investigator discretion, with antifungal prophylaxis. Receives: Drug: Venetoclax; Drug: Azacitidine; Drug: Decitabine; Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite remission rate (CR + CRi) after one cycle
Proportion of participants achieving complete remission (bone marrow blasts <5%, absence of circulating blasts and Auer rods, no extramedullary disease, ANC ≥1000/µL, platelets ≥100,000/µL) or CR with incomplete haematologic recovery (all CR criteria except residual neutropenia or thrombocytopenia), assessed on Day 28 bone marrow examination.
Measured: Day 28 (end of cycle 1)
Secondary outcomes (8)
Change in total WBC count from baseline
Measured: Baseline and Day 28
Change in absolute/differential neutrophil count from baseline
Measured: Baseline and Day 28
Change in haemoglobin concentration from baseline
Measured: Baseline and Day 28
Change in platelet count from baseline
Measured: Baseline and Day 28
Change in peripheral blood blast percentage from baseline
Measured: Baseline and Day 28
Change in bone marrow blast percentage from baseline
Measured: Baseline and Day 28
Number of participants with treatment-emergent adverse events
Measured: Day 1 to Day 28
All-cause mortality
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jun 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talha Islam Zinan, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773909
- Sponsor's protocol ID
- ERC-DMC/ECC/2022/318
- Other IDs
- ERC-DMC/ECC/2022/318
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Outcome of Newly Diagnosed Acute Myeloid Leukemia Treated With Hypomethylating Agents and Venetoclax in Patients Ineligible for Intensive Chemotherapy: A Single-Centre Prospective Study
- ClinicalTrials.gov ID
- NCT07773909
- Acronym / sponsor ID
- ERC-DMC/ECC/2022/318
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 19 Aug 2026 (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 single-arm interventional study evaluated the short-term outcome of one 28-day cycle of venetoclax combined with a hypomethylating agent (azacitidine or decitabine) in adults with newly diagnosed acute myeloid leukemia who could not receive intensive induction chemotherapy. Twenty-four patients were enrolled at the Department of Haematology, Dhaka Medical College Hospital, Dhaka, Bangladesh. In addition to older and comorbid patients, the cohort included younger patients for whom intensive chemotherapy was financially inaccessible - a population under-represented in existing trial and registry data. The primary endpoint was the composite remission rate (complete remission plus complete remission with incomplete haematologic recovery) assessed by bone marrow examination on Day 28. Secondary endpoints included change in complete blood count parameters, treatment-emergent adverse events, and 28-day mortality.
Detailed description
Background and Rationale
Acute myeloid leukemia (AML) predominantly affects older adults, who often cannot tolerate intensive induction chemotherapy due to comorbidity or poor performance status. In low- and middle-income countries like Bangladesh, a secondary population-younger, medically fit patients-is also unable to receive intensive therapy due to prohibitive costs. While hypomethylating agents (HMAs) combined with venetoclax represent a standard lower-intensity approach, real-world data on this regimen are lacking in Bangladesh and sparse for financially constrained younger cohorts. This study evaluates the short-term outcomes of a single cycle of venetoclax plus an HMA in both groups at a public tertiary care hospital.
Intervention Details \& Dosing Nuances
Participants receive one 28-day cycle consisting of either IV azacitidine (75 mg/m² daily on Days 1-7) or IV decitabine (20 mg/m² daily on Days 1-5), based on physician discretion. Oral venetoclax is administered at 100 mg on Day 1, 200 mg on Day 2, and maintained at 100 mg daily from Day 3 to Day 28. The venetoclax dose is intentionally capped at 100 mg daily (instead of standard higher dosing) because all participants receive concomitant oral voriconazole (200 mg twice daily, Days 3-28) for antifungal prophylaxis, a strong CYP3A4 inhibitor requiring mandatory venetoclax dose reduction. Tumour lysis syndrome prophylaxis and standard supportive care (transfusions, antimicrobials) are provided per institutional protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax + Hypomethylating Agent | Experimental | Drug: Venetoclax, Drug: Azacitidine, Drug: Decitabine, Drug: VoriconazoleSingle arm. All participants received one 28-day cycle of venetoclax combined with either azacitidine or decitabine at investigator discretion, with antifungal prophylaxis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed acute myeloid leukemia
- Age 18 years or older
- Deemed ineligible for intensive chemotherapy by the treating physician based on age (≥60 years), performance status or comorbidity, financial constraints, or patient unwillingness to receive intensive chemotherapy
- Written informed consent
Key exclusion criteria (2 listed)
- Acute promyelocytic leukemia
- Previous treatment with a hypomethylating agent
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 |
|---|---|---|
| VenetoclaxOral venetoclax 100 mg on Day 1, 200 mg on Day 2, then 100 mg daily Days 3-28. Dose maintained at 100 mg from Day 3 because of concomitant strong CYP3A4 inhibition by voriconazole. | Drug | Venetoclax + Hypomethylating Agent |
| Azacitidine75 mg/m² intravenously, Days 1-7 of the 28-day cycle. | Drug | Venetoclax + Hypomethylating Agent |
| Decitabine20 mg/m² intravenously, Days 1-5 of the 28-day cycle. | Drug | Venetoclax + Hypomethylating Agent |
| Voriconazole200 mg orally twice daily, Days 3-28, as antifungal prophylaxis. | Drug | Venetoclax + Hypomethylating Agent |
Primary outcome
Composite remission rate (CR + CRi) after one cycle
Time frame: Day 28 (end of cycle 1)
Proportion of participants achieving complete remission (bone marrow blasts <5%, absence of circulating blasts and Auer rods, no extramedullary disease, ANC ≥1000/µL, platelets ≥100,000/µL) or CR with incomplete haematologic recovery (all CR criteria except residual neutropenia or thrombocytopenia), assessed on Day 28 bone marrow examination.
8 secondary outcomes
Change in total WBC count from baseline
Time frame: Baseline and Day 28
Change in absolute/differential neutrophil count from baseline
Time frame: Baseline and Day 28
Change in haemoglobin concentration from baseline
Time frame: Baseline and Day 28
Change in platelet count from baseline
Time frame: Baseline and Day 28
Change in peripheral blood blast percentage from baseline
Time frame: Baseline and Day 28
Change in bone marrow blast percentage from baseline
Time frame: Baseline and Day 28
Number of participants with treatment-emergent adverse events
Time frame: Day 1 to Day 28
All-cause mortality
Time frame: Day 1 to Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venetoclax, Azacitidine and Decitabine in people with Acute Myeloid Leukemia, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite remission rate (CR + CRi) after one cycle (time frame: Day 28 (end of cycle 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.