Acute Myeloid LeukemiaPhase 2NCT05029141
New Double Epigenetic Regimen in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
A Phase 2 study testing CAHAG regimen in people with Acute Myeloid Leukemia and Refractory Acute Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study is to investigate the therapeutic efficacy and side effect of chidamide, azacitidine combined with priming HAG regimen for relapsed or refractroy acute myeloid leukemia Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Acute Myeloid Leukemia, Refractory Acute Leukemia, Relapsed Adult AML
- What is being tested?
- CAHAG regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Aug 2027
- Phase
- Phase 2
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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 18 and ≤ 70 years
- Patients diagnosed with AML according to 2016 WHO myeloid malignant disease diagnosis standard (Non-APL)
- Patients with AML must meet one of the following criteria, A or B:
- A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) < 50% and > 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse.
- ECOG performance status score less than 3
- Expected survival time ˃ 3 months
- Patients without serious heart, lung, liver, or kidney disease
- Ability to understand and voluntarily provide informed consent
Who cannot join
- Patients who are allergic to the study drug or drugs with similar chemical structures
- Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception
- Active infection
- Active bleeding
- Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment
- Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met
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- Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the normal range, ALT/AST > 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the normal value)
- Patients with a history of clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment
- Surgery on the main organs within the past six weeks
- Drug abuse or long-term alcohol abuse that would affect the evaluation results
- Patients who have received organ transplants (excepting bone marrow transplantation)
- Patients not suitable for the study according to the investigator's assessment
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: A Multi-center, Randomized Clinical Trial of Chidamide Combined With Azacytidine and the HAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Patients
This study is to investigate the therapeutic efficacy and side effect of chidamide, azacitidine combined with priming HAG regimen for relapsed or refractroy acute myeloid leukemia
- Being tested
- CAHAG regimen, Placebo regimen
- Keywords
- chidamide, Azacitidine, priming regimen
- 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.
CAHAG regimenDrug
Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC > 20×10E9/L, G-CSF paused).
One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial.
Placebo regimenDrug
Chidamide 0mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC > 20×10E9/L, G-CSF paused).
One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide+AZA+HHT+AraC+G-CSF group | Experimental | The patients are randomized into the group. Patients whose last induction failure regimen is a demethylated agent combined with priming regimen enter the experimental group directly. Receives: Drug: CAHAG regimen |
| Placebo+AZA+HHT+AraC+G-CSF group | Placebo comparator | The patients are randomized into the group. Receives: Drug: Placebo regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The overall response (completed remission without minimal residual disease, completed remission with incomplete blood count recovery, morphologic leukemia-free state and partial remission) rate achieved after one or two courses(28 days) induction therapy by CAHAG regimen.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Complete remission without minimal residual disease (CR with MRD-)
If studied pretreatment, CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC
Measured: At the end of Cycle 1 (each cycle is 28 days)
Complete remission with incomplete hematologic recovery (CRi)
All CR criteria except for residual neutropenia (,1.0*10E9/L [1000/uL]) or thrombocytopenia (<100*10E9/L [100 000/uL])
Measured: At the end of Cycle 1 (each cycle is 28 days)
Morphologic leukemia-free state (MLFS)
Bone marrow blasts ,5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required
Measured: At the end of Cycle 1 (each cycle is 28 days)
Partial remission (PR)
All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (3)
Duration of Response (DOR)
It is measured the time from initial response to subsequent disease progression or relapse.
Measured: 1 year
Overall Survival (OS)
It is measured from the time of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Measured: 1 year
Progression-Free Survival (PFS)
It is measured from the time from randomization to progression or death.
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 posted31 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, West China Hospital, Fujian Medical University Union Hospital, The First Hospital of Jilin University, Anhui Provincial Hospital, Qilu Hospital of Shandong University, Zhengzhou University, Shandong Provincial Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Harbin Medical University, Xinqiao Hospital of Chongqing
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029141
- Sponsor's protocol ID
- SZCAHAG
- Status last verified
- Mar 2026
- First submitted
- 16 Aug 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No