Acute Myeloid LeukemiaPhase 2NCT06827899
Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated AML
A Phase 2 study testing veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML) Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed acute myeloid leukemia (non-M3). Have not received treatment before and cannot accept standard cytarabine and anthracycline induction regimen treatment due to age or comorbidity or patient preference;
- Age >= 60 years old, male or female, expected survival time greater than 3 months;
- Estimated creatinine clearance >= 30 mL/min;
- AST and ALT <= 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin <= 1.5 x ULN (unless considered due to leukemic organ involvement);
- ECOG <= 2;
- Able to understand and voluntarily provide informed consent.
Who cannot join
- Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16);
- Active central nervous system leukemia;
- A history of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myelogenous leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR- ABL1 translocation;
- HIV-positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive tests);
- Suffering from chronic respiratory diseases requiring continuous oxygen inhalation, or having an obvious history of kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases;
- Suffering from malabsorption syndrome or other diseases that exclude the enteral route of administration;
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- Clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction, and congestive heart failure within one year before enrollment patients, and patients with coronary heart disease who have clinical symptoms and need drug treatment;
- Active, uncontrolled severe infection;
- There is a history of other malignant tumors within 2 years, except for the following cases: adequately treated carcinoma in situ of the cervix or carcinoma in situ of the breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- White blood cell count > 25 x 10^9/L (hydroxyurea or leukapheresis can meet this standard);
- Mental disorders that will hinder research participation;
- Participants have received the following treatments: hypomethylation agents, venetoclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation;
- Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial.
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
Bing Xu
Xiamen, Fujian, 361000
Bing Xu, +8618750918842, xubingzhangjian@126.com
Zhifeng Li, +8613606901162, lzf_xm@163.com
About this study
Official title: A Multicenter, Prospective, Single-arm Clinical Study of Veneclax, Chidaniline Combined With Azacitidine (VCA) Followed by Decitabine + MAG Regimen (D-MAG) in the Treatment of Elderly Untreated Acute Myeloid Leukemia (AML)
A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)
Read the detailed description
A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)
- Conditions
- Acute Myeloid Leukemia
- Being tested
- veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)
- 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.
veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) | Experimental | Not described Receives: Drug: veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
Defined as the time interval from treatment initiation to the occurrence of induction failure, relapse, or death, whichever came first.
Measured: Up to 60 months
Secondary outcomes (4)
Complete Remission (CR) rate
The percent of participants with complete remission (CR) was defined in accordance with the IWG Response Criteria in AML.
Measured: Up to 60 months
Overall Survival (OS)
OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.
Measured: Up to 60 months
Overall Response Rate (ORR)
Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).
Measured: Up to 60 months
General Health Status/Quality of Life
Will be assessed by Questionnaire.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Jul 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (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.
- More trials run by The First Affiliated Hospital of Xiamen 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
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Provincial Hospital, Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Jieyang People's Hospital, Huizhou Municipal Central Hospital
- Responsible party
- Principal investigator, Bing, Xu, The First Affiliated Hospital of Xiamen University
- Investigators
- Bing Xu, Principal investigator, The First Aiffiliated hosptical of xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827899
- Sponsor's protocol ID
- XMDYYYXYK-04
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Single-arm Clinical Study of Veneclax, Chidaniline Combined With Azacitidine (VCA) Followed by Decitabine + MAG Regimen (D-MAG) in the Treatment of Elderly Untreated Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT06827899
- Acronym / sponsor ID
- XMDYYYXYK-04
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Collaborators
- Fujian Provincial Hospital, Fujian Cancer Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Jieyang People's Hospital, Huizhou Municipal Central Hospital
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Feb 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.
A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)
Detailed description
A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) | Experimental | Drug: veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed acute myeloid leukemia (non-M3). Have not received treatment before and cannot accept standard cytarabine and anthracycline induction regimen treatment due to age or comorbidity or patient preference;
- Age >= 60 years old, male or female, expected survival time greater than 3 months;
- Estimated creatinine clearance >= 30 mL/min;
- AST and ALT <= 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin <= 1.5 x ULN (unless considered due to leukemic organ involvement);
- ECOG <= 2;
Key exclusion criteria (13 listed)
- Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16);
- Active central nervous system leukemia;
- A history of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myelogenous leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR- ABL1 translocation;
- HIV-positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive tests);
- Suffering from chronic respiratory diseases requiring continuous oxygen inhalation, or having an obvious history of kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases;
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 |
|---|---|---|
| veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)Specified dose on specified days | Drug | veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) |
Primary outcome
Event-free survival (EFS)
Time frame: Up to 60 months
Defined as the time interval from treatment initiation to the occurrence of induction failure, relapse, or death, whichever came first.
4 secondary outcomes
Complete Remission (CR) rate
Time frame: Up to 60 months
Overall Survival (OS)
Time frame: Up to 60 months
Overall Response Rate (ORR)
Time frame: Up to 60 months
General Health Status/Quality of Life
Time frame: Up to 60 months
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 20 Feb 2025.
- 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.
Bing Xu principal investigator
The First Aiffiliated hosptical of xiamen 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 veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Xiamen 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 6 inclusion and 13 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 20 Feb 2025. 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 Bing Xu (+8618750918842, xubingzhangjian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: Up to 60 months). 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 20 Feb 2025.