Intermediate Risk Acute Myeloid LeukemiaPhase 2NCT06394011
Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients
A Phase 2 study testing venetoclax, azacitidine and HAAG regimen in people with Intermediate Risk Acute Myeloid Leukemia and High Risk Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intermediate Risk Acute Myeloid Leukemia, High Risk Acute Myeloid Leukemia
- What is being tested?
- venetoclax, azacitidine and HAAG regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2024to 30 Dec 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
- Age 18-65.
- ECOG score: 0-2.
- No history of previous chemotherapy or target therapy.
- Serum total bilirubin <= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) <= 1.5 times ULN, aspartate aminotransferase (AST) <=1.5 times ULN;
- Creatinine clearance rate >=30 mL/min;
- Serum lipase <= 1.5 times ULN, amylase <= 1.5 times ULN;
- Capable to understand and willing to participate in this study, signed the informed consent form.
Who cannot join
- AML transformed with chronic myelogenous leukemia.
- Acute promyelocytic leukemia (type M3).
- Patients with a second malignancy requiring treatment.
- Patients with uncontrolled active infection.
- Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with hepatic and renal inadequacy: total serum bilirubin >=2.0 mg/dl, AST >=3 times ULN, serum creatinine clearance (Ccr) <50 ml / min.
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- Patients with arterial oxygen saturation (SpO 2) was <95%.
- Patients with HIV infection.
- Patients with active hepatitis B or hepatitis C infection.
- Patients with other commodities that the investigators considered not suitable for the enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaowen Tang, Ph.D, (0086)51267780086, xwtang1020@163.com
Depei Wu, Ph.D, (0086)51267780086, drwudepei@163.com
About this study
Official title: A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia
The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.
Read the detailed description
This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.
- Being tested
- venetoclax, azacitidine and HAAG regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venetoclax, azacitidine and HAAG regimenDrug
Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3~10, per os; Azacitidine:75mg/m2/d, d1~7, subcutaneous injection; Homoharringtonine:1mg/d, d4~10, intravenous infusion; Aclarubicin:10mg/d, d4~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection;
| Study group | Role | What they receive |
|---|---|---|
| VA combined with HAAG | Experimental | This cohort will determine the safety and efficacy of venetoclax, azacitidine combined with HAAG regimen in newly diagnosed intermediate and high-risk AML patients. Receives: Drug: venetoclax, azacitidine and HAAG regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite complete response rate (CRc; CR+CRi)
CRc includes complete response CR and CRi; CR was defined as < 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as<5% bone marrow blasts, either ANC<1×10^9/L or platelets<100×10^9/L, transfusion independence but with persistence of cytopenia.
Measured: Day 28-35 of induction course
Secondary outcomes (4)
Partial remission (PR)
PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.
Measured: Day 28-35 of induction course
Number of adverse events
adverse events are evaluated with CTCAE V5.0.
Measured: 2 years
Relapse-free survival (RFS)
time from clinical CRc (CR and CRi) to the first relapse or death
Measured: 3 years
Overall survival (OS)
time from the first day of treatment to death or lost to follow-up for any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 Feb 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate Risk Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaowen Tang, Ph.D, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394011
- Sponsor's protocol ID
- VA+HAAG
- Status last verified
- Jan 2024
- First submitted
- 27 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06394011
- Acronym / sponsor ID
- VA+HAAG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 May 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 purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.
Detailed description
This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VA combined with HAAG | Experimental | Drug: venetoclax, azacitidine and HAAG regimenThis cohort will determine the safety and efficacy of venetoclax, azacitidine combined with HAAG regimen in newly diagnosed intermediate and high-risk AML patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
- Age 18-65.
- ECOG score: 0-2.
- No history of previous chemotherapy or target therapy.
- Serum total bilirubin <= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) <= 1.5 times ULN, aspartate aminotransferase (AST) <=1.5 times ULN;
Key exclusion criteria (10 listed)
- AML transformed with chronic myelogenous leukemia.
- Acute promyelocytic leukemia (type M3).
- Patients with a second malignancy requiring treatment.
- Patients with uncontrolled active infection.
- Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
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, azacitidine and HAAG regimenVenetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3~10, per os; Azacitidine:75mg/m2/d, d1~7, subcutaneous injection; Homoharringtonine:1mg/d, d4~10, intravenous infusion; Aclarubicin:10mg/d, d4~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection; | Drug | VA combined with HAAG |
Primary outcome
Composite complete response rate (CRc; CR+CRi)
Time frame: Day 28-35 of induction course
CRc includes complete response CR and CRi; CR was defined as < 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as<5% bone marrow blasts, either ANC<1×10^9/L or platelets<100×10^9/L, transfusion independence but with persistence of cytopenia.
4 secondary outcomes
Partial remission (PR)
Time frame: Day 28-35 of induction course
Number of adverse events
Time frame: 2 years
Relapse-free survival (RFS)
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
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 May 2024.
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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.
Xiaowen Tang, Ph.D study chair
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing venetoclax, azacitidine and HAAG regimen in people with Intermediate Risk Acute Myeloid Leukemia and High Risk Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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 8 inclusion and 10 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 1 May 2024. 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 China. 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 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 Xiaowen Tang, Ph.D ((0086)51267780086, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite complete response rate (CRc; CR+CRi) (time frame: Day 28-35 of induction course). 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 May 2024.