Acute Monocytic LeukemiaPhase 2NCT07512700
Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia
A Phase 2 study testing CACAG+VEN and 3+7 in people with Acute Monocytic Leukemia, run by Chinese PLA General Hospital at 3 sites in China.
Trial summary
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Acute Monocytic Leukemia
- What is being tested?
- CACAG+VEN and 3+7
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2025to 31 Oct 2029
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures.
- Age 14 to 60 years at screening, no gender restriction.
- Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia.
- No history of severe allergic reactions.
- Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN.
- Renal function: serum creatinine ≤ 1.5 × ULN
- No uncontrolled infection or severe psychiatric disorder.
- ECOG performance status 0-3; life expectancy ≥ 4 months.
Who cannot join
- Known hypersensitivity or contraindication to any study drug.
- Pregnancy or lactation.
- Active infection.
- Long-term smoking or alcohol abuse that may interfere with study outcome evaluation.
- Psychiatric illness or other condition that prevents informed consent or compliance with study procedures.
- Major organ surgery within 6 weeks prior to enrollment.
- Abnormal liver function: total bilirubin > 2× ULN, ALT/AST > 2.5 × ULN; abnormal renal function: serum creatinine > 1.5 × ULN.
- Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Air Force Medical Center, PLA
Beijing
Liping Dou, Doctor, +8613681207138, lipingruirui@163.com
- Recruiting
Chinese PLA General Hospital
Beijing
Liping Dou, Doctor, +8613681207138, lipingruirui@163.com
Daihong Liu, Doctor, +8613681171597, daihongrm@163.com
- Recruiting
PLA Strategic Support Force's Characteristic Medical Center
Beijing
Liping Dou, Doctor, +8613681207138, lipingruirui@163.com
About this study
Official title: Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia: A Prospective, Randomized, Controlled Study
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
Read the detailed description
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
A total of 204 participants, aged 14 to 60 years, will be enrolled across multiple study sites in China. Participants will be randomly assigned to one of two treatment groups:
Group 1: Venetoclax combined with the CACAG (cytarabine, azacitidine, chidamide, aclarubicin and granulocyte colony-stimulating factor) regimen This group will receive a combination of azacitidine, cytarabine, aclarubicin, chidamide, and venetoclax, along with granulocyte colony-stimulating factor (G-CSF) support.
Group 2: The standard "3+7" regimen This group will receive standard induction chemotherapy with daunorubicin and cytarabine.
The total study treatment period is about 8-10 weeks, consisting of two treatment cycles. Participants who do not achieve at least a partial response after the first cycle may be withdrawn from the study to receive alternative treatment as recommended by clinical guidelines.
The main goal of the study is to evaluate and compare the effectiveness of these two regimens in treating acute monocytic leukemia. Outcomes will include treatment response, safety, and overall patient outcomes during the study period.
- Conditions
- Acute Monocytic Leukemia
- Being tested
- CACAG+VEN, 3+7
- Keywords
- Acute Monocytic Leukemia, Venetoclax+CACAG
- Medical subject headings
- Leukemia, Monocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CACAG+VENDrug
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor
- Azacytidine (75 mg/m2/day, days 1 to 7).
- Cytarabine (75-100 mg/m2 every 12 hrs, days 1 to 5).
- Aclacinomycin (20 mg/day, days 1,3,5).
- Chidamide (30 mg/day , days 1,4,8,11).
- Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. 6.Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery.
3+7Drug
IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
DA regimen: 1.Daunorubicin(60 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
MA regimen: 1.Mitoxantrone (12 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax Combined with CACAG Regimen | Experimental | Participants assigned to Venetoclax Combined with CACAG Regimen will receive a combination regimen consisting of venetoclax plus the CACAG. The CACAG regimen includes azacitidine administered at a dose of 75 mg/m² subcutaneously on days 1-7; cytarabine given at a dose of 75-100 mg/m² q12h intravenously on days 1-5; aclarubicin administered at a dose of 20 mg intravenously on days 1, 3, and 5; and chidamide given orally at a dose of 30 mg twice a week for two weeks. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles. Receives: Drug: CACAG+VEN |
| Standard "3+7" Regimen | Active comparator | Participants assigned toStandard "3+7" Regimen will receive the standard "3+7" induction regimen. Daunorubicin is administered intravenously at a dose of 60 mg/m² on days 1-3. Cytarabine is given intravenously at a dose of 75-100 mg/m² twice daily on days 1-7. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles. Participants who do not achieve at least a partial response after the first cycle will be withdrawn from the study and receive alternative treatment according to clinical guidelines. Receives: Drug: 3+7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Remission Rate
Proportion of participants achieving composite complete remission (CRc = CR + CRi) after one cycle of treatment. CR is defined as no clinical leukemic symptoms, hemoglobin ≥100 g/L (male) or ≥90 g/L (female/children), ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, no blasts in peripheral blood, and bone marrow blasts ≤5% with normal erythroid and megakaryocytic lineages. CRi meets all CR criteria except residual neutropenia (ANC <1.0×10⁹/L) or thrombocytopenia (platelets <100×10⁹/L).
Measured: At the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes (16)
Complete Remission Rate after Cycle 1
Proportion of participants achieving complete remission (CR) after one cycle of treatment. CR is defined as absence of clinical symptoms and signs of leukemic infiltration; hemoglobin ≥100 g/L (male) or ≥90 g/L (female and children), absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, no blasts in peripheral blood differential, and bone marrow blasts (type I + II) ≤5% with normal erythroid and megakaryocytic lineages.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission with Incomplete Count Recovery Rate after Cycle 1
Proportion of participants achieving complete remission with incomplete count recovery (CRi) after one cycle of treatment. CRi is defined as meeting all CR criteria except for residual neutropenia (absolute neutrophil count <1.0×10⁹/L) or thrombocytopenia (platelet count <100×10⁹/L).
Measured: At the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate after Cycle 1
Proportion of participants achieving overall response after one cycle of treatment. Overall response is defined as the sum of complete remission (CR), complete remission with incomplete count recovery (CRi), and partial remission (PR).
Measured: At the end of Cycle 1 (each cycle is 28 days)
Partial Remission Rate after Cycle 1
Proportion of participants achieving partial remission (PR) after one cycle of treatment. PR is defined as a reduction of bone marrow blasts by more than 50%, with a final blast percentage between 5% and 25%, and recovery of peripheral blood counts to normal.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Minimal Residual Disease Negative Rate after Cycle 1
Proportion of participants achieving minimal residual disease (MRD) negativity after one cycle of treatment. MRD negativity is defined as the absence of measurable residual disease as assessed by immunologic or molecular methods.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Composite Complete Remission Rate after Cycle 1
Proportion of participants achieving composite complete remission (CRc = CR + CRi) after two cycles of treatment.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission Rate after Cycle 2
Proportion of participants achieving complete remission (CR) after two cycles of treatment. CR is defined as absence of clinical symptoms and signs of leukemic infiltration; hemoglobin ≥100 g/L (male) or ≥90 g/L (female and children), absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, no blasts in peripheral blood differential, and bone marrow blasts (type I + II) ≤5% with normal erythroid and megakaryocytic lineages.
Measured: At the end of Cycle 2 (each cycle is 28 days)
Complete Remission with Incomplete Count Recovery Rate after Cycle 2
Proportion of participants achieving complete remission with incomplete count recovery (CRi) after two cycles of treatment. CRi is defined as meeting all CR criteria except for residual neutropenia (absolute neutrophil count <1.0×10⁹/L) or thrombocytopenia (platelet count <100×10⁹/L).
Measured: At the end of Cycle 2 (each cycle is 28 days)
Partial Remission Rate after Cycle 2
Proportion of participants achieving partial remission (PR) after two cycles of treatment. PR is defined as a reduction of bone marrow blasts by more than 50%, with a final blast percentage between 5% and 25%, and recovery of peripheral blood counts to normal.
Measured: At the end of Cycle 2 (each cycle is 28 days)
Minimal Residual Disease Negative Rate after Cycle 2
Proportion of participants achieving minimal residual disease (MRD) negativity after two cycles of treatment. MRD negativity is defined as the absence of measurable residual disease as assessed by immunologic or molecular methods.
Measured: At the end of Cycle 2 (each cycle is 28 days)
Progression-Free Survival
The time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first. Disease progression is defined according to standard criteria for acute monocytic leukemia.
Measured: Up to 12 months after enrollment
Overall Survival
The time from enrollment to death from any cause. For surviving participants, data will be censored at the date of last follow-up.
Measured: Up to 12 months after enrollment
Relapse Rate
The proportion of participants who achieve remission (CR or CRi) and subsequently experience disease relapse during the follow-up period. Relapse is defined according to standard criteria for acute monocytic leukemia.
Measured: Up to 12 months after enrollment
Duration of Remission
The time from the first documented remission (CR or CRi) to disease relapse or death from any cause, whichever occurs first.
Measured: Up to 12 months after enrollment
Adverse reactions in hematology
Record of adverse events in hematological system during and after treatment
Measured: At the end of Cycle 2 (each cycle is 28 days)
Nonhematological adverse reactions
Record of adverse events in other organs or systmes during and after treatment
Measured: At the end of Cycle 2 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Monocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, PLA Strategic Support Force's Characteristic Medical Center
- Responsible party
- Principal investigator, Liping Dou, Chinese PLA General Hospital
- Investigators
- Liping Dou, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512700
- Sponsor's protocol ID
- 2025-761
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07512700
- Acronym / sponsor ID
- 2025-761
- Conditions
- Acute Monocytic Leukemia
- Keywords
- Acute Monocytic Leukemia, Venetoclax+CACAG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, PLA Strategic Support Force's Characteristic Medical Center
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 6 Apr 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 study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
Detailed description
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
A total of 204 participants, aged 14 to 60 years, will be enrolled across multiple study sites in China. Participants will be randomly assigned to one of two treatment groups:
Group 1: Venetoclax combined with the CACAG (cytarabine, azacitidine, chidamide, aclarubicin and granulocyte colony-stimulating factor) regimen This group will receive a combination of azacitidine, cytarabine, aclarubicin, chidamide, and venetoclax, along with granulocyte colony-stimulating factor (G-CSF) support.
Group 2: The standard "3+7" regimen This group will receive standard induction chemotherapy with daunorubicin and cytarabine.
The total study treatment period is about 8-10 weeks, consisting of two treatment cycles. Participants who do not achieve at least a partial response after the first cycle may be withdrawn from the study to receive alternative treatment as recommended by clinical guidelines.
The main goal of the study is to evaluate and compare the effectiveness of these two regimens in treating acute monocytic leukemia. Outcomes will include treatment response, safety, and overall patient outcomes during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venetoclax Combined with CACAG Regimen | Experimental | Drug: CACAG+VENParticipants assigned to Venetoclax Combined with CACAG Regimen will receive a combination regimen consisting of venetoclax plus the CACAG. The CACAG regimen includes azacitidine administered at a dose of 75 mg/m² subcutaneously on days 1-7; cytarabine given at a dose of 75-100 mg/m² q12h intravenously on days 1-5; aclarubicin administered at a dose of 20 mg intravenously on days 1, 3, and 5; and chidamide given orally at a dose of 30 mg twice a week for two weeks. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles. |
| Standard "3+7" Regimen | Active comparator | Drug: 3+7Participants assigned toStandard "3+7" Regimen will receive the standard "3+7" induction regimen. Daunorubicin is administered intravenously at a dose of 60 mg/m² on days 1-3. Cytarabine is given intravenously at a dose of 75-100 mg/m² twice daily on days 1-7. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles. Participants who do not achieve at least a partial response after the first cycle will be withdrawn from the study and receive alternative treatment according to clinical guidelines. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures.
- Age 14 to 60 years at screening, no gender restriction.
- Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia.
- No history of severe allergic reactions.
- Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN.
Key exclusion criteria (8 listed)
- Known hypersensitivity or contraindication to any study drug.
- Pregnancy or lactation.
- Active infection.
- Long-term smoking or alcohol abuse that may interfere with study outcome evaluation.
- Psychiatric illness or other condition that prevents informed consent or compliance with study procedures.
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 |
|---|---|---|
| CACAG+VENAzacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor 1. Azacytidine (75 mg/m2/day, days 1 to 7). 2. Cytarabine (75-100 mg/m2 every 12 hrs, days 1 to 5). 3. Aclacinomycin (20 mg/day, days 1,3,5). 4. Chidamide (30 mg/day , days 1,4,8,11). 5. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. 6.Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery. | Drug | Venetoclax Combined with CACAG Regimen |
| 3+7IA regimen: 1. Idarubicin (8-10 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. DA regimen: 1.Daunorubicin(60 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. MA regimen: 1.Mitoxantrone (12 mg/m2) for 3 days. 2.Cytarabine (75-100mg/m2, every 12 hrs) for 7 days. | Drug | Standard "3+7" Regimen |
Primary outcome
Composite Complete Remission Rate
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Proportion of participants achieving composite complete remission (CRc = CR + CRi) after one cycle of treatment. CR is defined as no clinical leukemic symptoms, hemoglobin ≥100 g/L (male) or ≥90 g/L (female/children), ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, no blasts in peripheral blood, and bone marrow blasts ≤5% with normal erythroid and megakaryocytic lineages. CRi meets all CR criteria except residual neutropenia (ANC <1.0×10⁹/L) or thrombocytopenia (platelets <100×10⁹/L).
16 secondary outcomes
Complete Remission Rate after Cycle 1
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission with Incomplete Count Recovery Rate after Cycle 1
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate after Cycle 1
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Partial Remission Rate after Cycle 1
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Minimal Residual Disease Negative Rate after Cycle 1
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Composite Complete Remission Rate after Cycle 1
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission Rate after Cycle 2
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Complete Remission with Incomplete Count Recovery Rate after Cycle 2
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Partial Remission Rate after Cycle 2
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Minimal Residual Disease Negative Rate after Cycle 2
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Progression-Free Survival
Time frame: Up to 12 months after enrollment
Overall Survival
Time frame: Up to 12 months after enrollment
Relapse Rate
Time frame: Up to 12 months after enrollment
Duration of Remission
Time frame: Up to 12 months after enrollment
Adverse reactions in hematology
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Nonhematological adverse reactions
Time frame: At the end of Cycle 2 (each cycle is 28 days)
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 6 Apr 2026.
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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.
Liping Dou, Doctor principal investigator
Chinese PLA General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CACAG+VEN and 3+7 in people with Acute Monocytic Leukemia, run by Chinese PLA General Hospital at 3 sites 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 8 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Liping Dou, Doctor (+8613681207138, lipingruirui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Complete Remission Rate (time frame: At the end of Cycle 2 (each cycle is 28 days)). 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 6 Apr 2026.