Acute Myeloid LeukemiaNCT05772273
PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT
A study testing Azacitidine, Donor lymphocyte infusion and Camrelizumab in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of PD-1 inhibitor, Azacitidine, and low-dose DLI in AML relapse After allogeneic hematopoietic stem cell transplantation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Azacitidine, Donor lymphocyte infusion and Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2023to 31 Dec 2027
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a diagnosis of AML relapse after allogeneic hematopoietic stem cell transplantation.
- Adequate organ function.
- Be able to understand and sign informed consent.
- Age 18 to 60 years old.
- Serum pregnancy test for females of childbearing potential that is negative within one week prior to initiation of first dose of treatment. Female patients of childbearing potential and sexually active males must agree to use a highly effective method of contraception throughout the study and for at least 90 days after the last dose of assigned treatment.
- ECOG performance status ≤ 1.
- Known HLA-matched donor without contraindications to donate.
- Life expectancy > 3 months.
Who cannot join
- Diagnosis of anther malignant disease.
- Suspected or proven acute or chronic GVHD.
- Proven central nervous system leukemia.
- Prior treatment with anti-PD-1, anti-PD-L1, or DLI.
- HLA loss positive.
- Known active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B (HBV) or C (HCV) or Corona Virus Disease 2019(COVID-19);
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- Uncontrolled systemic fungal, bacterial, or viral infection.
- Known or suspected hypersensitivity to PD-1 inhibitor or azacytidine.
- Participation in another clinical study within 3 months.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures.
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
Sheng-Li Xue, M.D., 0086-13328008851, slxue@suda.edu.cn
About this study
Official title: Efficacy and Safety of PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
This study aims to evaluate the efficacy and safety of PD-1 inhibitor, Azacitidine, and low-dose DLI in AML relapse After allogeneic hematopoietic stem cell transplantation
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Azacitidine, Donor lymphocyte infusion, Camrelizumab
- Keywords
- PD-1 inhibitor, Azacitidine, low-dose DLI
- 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.
AzacitidineDrug
Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.
Donor lymphocyte infusionBiological
The 4 DLI doses (dose range: ±10%) of sib-matched donor HSCT patients were 1×10^6/kg, 5×10^6/kg, 1×10^7/kg, 5×10^7/kg; The 4 DLI doses (dose range: ±10%) of haploidentical or unrelated donor HSCT patients were 1×10^5/kg, 5×10^5/kg, 1×10^6/kg, 5×10^6/kg.
CamrelizumabDrug
Camrelizumab 200mg Q2W for sib-matched donor HSCT patients, 100mg Q2W for haploidentical or unrelated donor HSCT patients.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion | Experimental | Patients are given azacytidine for 7 days, followed by 4 DLI treatments on Days 10, 17, 24 and 31, with the dose of DLI and Camrelizumab adjusted according to the donor source. Camrelizumab infusions were given 3 hours after completion of the 1st and 3rd DLIs, respectively. Receives: Drug: Azacitidine; Biological: Donor lymphocyte infusion; Drug: Camrelizumab |
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, completed remission with incomplete blood count recovery)
Measured: ORR assessment is at day 39 (±2).
Secondary outcomes (3)
Overall Survival (OS)
OS is measured from the time of enrollment to 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: 2 years
Progression-Free Survival (PFS)
PFS is measured from the time of enrollment to this study to progression or death.
Measured: 2 years
Adverse events
It is evaluated and graded according to CTCAE 5.0.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start15 Mar 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772273
- Sponsor's protocol ID
- MA-AML-Ⅱ-002
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05772273
- Acronym / sponsor ID
- MA-AML-Ⅱ-002
- Conditions
- Acute Myeloid Leukemia
- Keywords
- PD-1 inhibitor, Azacitidine, low-dose DLI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 2023 (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 aims to evaluate the efficacy and safety of PD-1 inhibitor, Azacitidine, and low-dose DLI in AML relapse After allogeneic hematopoietic stem cell transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion | Experimental | Drug: Azacitidine, Biological: Donor lymphocyte infusion, Drug: CamrelizumabPatients are given azacytidine for 7 days, followed by 4 DLI treatments on Days 10, 17, 24 and 31, with the dose of DLI and Camrelizumab adjusted according to the donor source. Camrelizumab infusions were given 3 hours after completion of the 1st and 3rd DLIs, respectively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a diagnosis of AML relapse after allogeneic hematopoietic stem cell transplantation.
- Adequate organ function.
- Be able to understand and sign informed consent.
- Age 18 to 60 years old.
- Serum pregnancy test for females of childbearing potential that is negative within one week prior to initiation of first dose of treatment. Female patients of childbearing potential and sexually active males must agree to use a highly effective method of contraception throughout the study and for at least 90 days after the last dose of assigned treatment.
Key exclusion criteria (10 listed)
- Diagnosis of anther malignant disease.
- Suspected or proven acute or chronic GVHD.
- Proven central nervous system leukemia.
- Prior treatment with anti-PD-1, anti-PD-L1, or DLI.
- HLA loss positive.
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 |
|---|---|---|
| AzacitidineAzacitidine 75 mg/m2 subcutaneously once daily on days 1-7. | Drug | Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion |
| Donor lymphocyte infusionThe 4 DLI doses (dose range: ±10%) of sib-matched donor HSCT patients were 1×10^6/kg, 5×10^6/kg, 1×10^7/kg, 5×10^7/kg; The 4 DLI doses (dose range: ±10%) of haploidentical or unrelated donor HSCT patients were 1×10^5/kg, 5×10^5/kg, 1×10^6/kg, 5×10^6/kg. | Biological | Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion |
| CamrelizumabCamrelizumab 200mg Q2W for sib-matched donor HSCT patients, 100mg Q2W for haploidentical or unrelated donor HSCT patients. | Drug | Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion |
Primary outcome
Overall response rate (ORR)
Time frame: ORR assessment is at day 39 (±2).
The overall response (completed remission, completed remission with incomplete blood count recovery)
3 secondary outcomes
Overall Survival (OS)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Adverse events
Time frame: 1 month
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 2 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azacitidine, Donor lymphocyte infusion and Camrelizumab in people with 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 2 Sep 2026. 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.
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 Sheng-Li Xue, M.D. (+86 512 6778 1139, slxue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: ORR assessment is at day 39 (±2).). 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 2 Sep 2026.