Acute Myeloid LeukemiaPhase 2NCT06598384
VA as Maintenance Therapy Post Allo-HSCT in MDS and AML
A Phase 2 study testing Venetoclax combined with Azacytidine in people with Acute Myeloid Leukemia, run by Navy General Hospital, Beijing.
Trial summary
The goal of this phase 2 trial is to test the safety and efficacy of Venetoclax combined with Azacytidine as Maintenance Therapy post Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venetoclax combined with Azacytidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2030
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
- The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- Patients aged ≥18 years with a diagnosis of MDS or AML according to World Health Organization criteria (WHO) who had undergone alloSCT with myeloablative or reduced-intensity conditioning regimens were eligible. Related and unrelated donors were permitted.
- Patients should be in morphologic complete remission (CR; ie, ≤5% bone marrow blasts) with absolute neutrophil counts ≥1.0×10^9 /L and platelets ≥ 75×10^ 9 /L before treatment.
Who cannot join
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yu Liu, PhD contact
About this study
Official title: Venetoclax Combined With Azacytidine as Maintenance Therapy Post Allogeneic Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia
The goal of this phase 2 trial is to test the safety and efficacy of Venetoclax combined with Azacytidine as Maintenance Therapy post Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia.
Read the detailed description
The investigators will evaluate the efficacy and safety of venetoclax combined with azacytidine as maintenance therapy post hematopoietic stem cell transplantation in myelodysplastic syndromes and acute myeloid leukemia. overall survival (OS), cumulative 1-year relapse- and progression-free survival (RPFS), time to relapse, relapse rate, incidence of acute and chronic GVHD, time to treatment discontinuation will be counted.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venetoclax combined with Azacytidine
- 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.
Venetoclax combined with AzacytidineDrug
Also called VA
Patients were treated by venetoclax and azacytidine:
Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-7; Azacytidine 75 mg/m2 subcutaneous injection qd d1-5.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax combined with Azacytidine | Experimental | Patients were treated by venetoclax and azacytidine Receives: Drug: Venetoclax combined with Azacytidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Rate
Relapse following CR is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.
Measured: 1 year
Secondary outcomes (2)
Overall Survival (OS)
OS was defined as time from diagnosis to death from any cause or the last follow-up
Measured: through study completion, an average of 2 years
Progression Free Survival (PFS)
For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liren Qian, Navy General Hospital, Beijing
- Investigators
- Liren Qian, Principal investigator, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598384
- Sponsor's protocol ID
- VAMHCT01
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax Combined With Azacytidine as Maintenance Therapy Post Allogeneic Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06598384
- Acronym / sponsor ID
- VAMHCT01
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 19 Sep 2024 (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.
The goal of this phase 2 trial is to test the safety and efficacy of Venetoclax combined with Azacytidine as Maintenance Therapy post Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndromes and Acute Myeloid Leukemia.
Detailed description
The investigators will evaluate the efficacy and safety of venetoclax combined with azacytidine as maintenance therapy post hematopoietic stem cell transplantation in myelodysplastic syndromes and acute myeloid leukemia. overall survival (OS), cumulative 1-year relapse- and progression-free survival (RPFS), time to relapse, relapse rate, incidence of acute and chronic GVHD, time to treatment discontinuation will be counted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax combined with Azacytidine | Experimental | Drug: Venetoclax combined with AzacytidinePatients were treated by venetoclax and azacytidine |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
- The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- Patients aged ≥18 years with a diagnosis of MDS or AML according to World Health Organization criteria (WHO) who had undergone alloSCT with myeloablative or reduced-intensity conditioning regimens were eligible. Related and unrelated donors were permitted.
- Patients should be in morphologic complete remission (CR; ie, ≤5% bone marrow blasts) with absolute neutrophil counts ≥1.0×10^9 /L and platelets ≥ 75×10^ 9 /L before treatment.
Key exclusion criteria (3 listed)
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- Pregnant or lactating women.
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 |
|---|---|---|
| Venetoclax combined with AzacytidineAlso: VAPatients were treated by venetoclax and azacytidine: Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-7; Azacytidine 75 mg/m2 subcutaneous injection qd d1-5. | Drug | Venetoclax combined with Azacytidine |
Primary outcome
Relapse Rate
Time frame: 1 year
Relapse following CR is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.
2 secondary outcomes
Overall Survival (OS)
Time frame: through study completion, an average of 2 years
Progression Free Survival (PFS)
Time frame: 1 year
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 1 Oct 2024.
- 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.
Yu Liu, PhD contact
Liren Qian principal investigator
Navy General Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax combined with Azacytidine in people with Acute Myeloid Leukemia, run by Navy General Hospital, Beijing.
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 3 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: opening soon, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Liren Qian, PhD (+861066947194, qlr2007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Rate (time frame: 1 year). 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 1 Oct 2024.