Acute Myeloid Leukemia (AML)Phase 2NCT06754540
Azacitidine Combined with Donor Lymphocyte Infusion for Acute Myeloid Leukemia Post-transplant Relapse Prevention.
A Phase 2 study testing Azacitidine (AZA) in people with Acute Myeloid Leukemia (AML) and Relapse, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Relapse
- What is being tested?
- Azacitidine (AZA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2025to 1 Jan 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Patients enrolled must meet the following criteria:
- ≥18 years old and ≤70 years old, male or female;
- Patients with haploid peripheral blood stem cell transplantation of AML;
- All patients received BU based myeloablative conditionings;
- A diagnosis of high-risk AML is one of the following:
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- ① Patients without morphologic CR before transplantation, including patients with initial refractory disease and recurrence.
- ② AML with poor prognosis (Standardized diagnosis and prognostic stratification of acute myeloid leukemia based on ELN edition which was 2022 Year) .
- Blood routine: neutrophils ≥1×10^9/L, platelet ≥50.0×10^9/L;
- There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD;
- The ECOG score is 0 to 2;
- Donor lymphocytes are available;
- The patient must be able to understand and be willing to participate in the study and sign an informed consent form.
Who cannot join
- Possible subjects who meet any of the following criteria will be excluded from the trial:
- Those who are allergic to known azacitidine or interferon
- Patients with active acute GVHD;
- Patients with moderate or more chronic GVHD;
- Non-haploid donor transplants;
- Patients who have not achieved complete remission after transplantation;
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- AML recurrence after transplantation (bone marrow, peripheral blood primitive cells ≥5% or extramedullary recurrence), or graft rejection, bone marrow donor cell chimeric rate (STR) <90%;
- Patient blood routine: ANC<1.0×10^9/L or PLT<50×10^9/L;
- Combined with severe organ dysfunction:liver function (AST/ALT) >3 times normal upper limit; the direct bilirubin > 3 times normal upper limit; renal function (Cr) < 50mL/min or >1.5 times normal upper limit, regardless of hemodialysis treatment;
- Patient with severe active infection;
- Pregnant or lactating women;
- Have received other interventions or are receiving other research drugs before the study begins;
- At the discretion of the investigator, other dangerous complications may result.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Azacitidine Combined with Donor Lymphocyte Infusion for Prevention of Recurrence After Haploid Hematopoietic Stem Cell Transplantation in High-risk Acute Myeloid Leukemia
This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML.
At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 51 patients, and collect demographic data, medical history data, vital signs, physical examination and laboratory tests (blood routine; urine routine; liver and kidney function;Immune indicators: T cell subsets, Treg, etc.), pregnancy tests for female patients and other necessary auxiliary inspections.The time to start treatment is from the +90 to +180 days after high-risk AML haploid hematopoietic stem cell transplantation.
Read the detailed description
1.Basic solution: Azacitidine is administered subcutaneously at 32 mg/m2/d for five consecutive days, starting no earlier than day +90 after HSCT, then repeated every 28 days for a total of twelve cycles. DLI is administered after an interval of 48 hours. Prophylactic DLI is given in escalating doses every four to six weeks for a total of three to four doses.The initial dose of DLI for haploid transplant patients is 1×10^5 CD3+/kg receptor weight lymphocytes gradually increased to 5×10^5, 1×10^6 and (2~5)×10^6 CD3+ Lymphocytes.
- Start time of medication: +90 ~ +120 days after transplantation.
- Donor lymphocyte infusion was preceded by anti-anaphylaxis,such as promethazine and hormone therapy was prohibited.
- In the course of AZA and DLI intervention, other targeted drugs such as venetoclax or chemotherapy drugs can be added on the basis of AZA if MRD or MRD increase (>1log) ,DLI continues as planned.
2.Stop treatment: Occurrence of any of the following conditions:
- Life-threatening complications.
- Acute GVHD above II degree; chronic GVHD above moderate manifestations or overlapping syndrome; No chronic GVHD is observed if acute GVHD remission is observed after discontinuation for 1 to 2 months, then preventive treatment is started again .
- Hematologic recurrence, graft rejection or bone marrow donor chimerism <90%.
- Conditions
- Acute Myeloid Leukemia (AML), Relapse
- Being tested
- Azacitidine (AZA)
- Keywords
- azacitidine, donor lymphocyte infusion, HSCT, haploid, high-risk, AML
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine (AZA)Drug
Azacitidine 32mg/m2
| Study group | Role | What they receive |
|---|---|---|
| AZA-DLI for acute myeloid leukemia post-transplant relapse preventiont | Experimental | One arm,Azacitidine is administered subcutaneously at 32 mg/m2/d for five consecutive days, starting no earlier than day +90 after HSCT, then repeated every 28 days for a total of twelve cycles. DLI is administered after an interval of 48 hours. Prophylactic DLI is given in escalating doses every four to six weeks for a total of three to four doses.The initial dose of DLI for haploid transplant patients is 1×10^5 CD3+/kg receptor weight lymphocytes gradually increased to 5×10^5, 1×10^6 and (2~5)×10^6 CD3+ Lymphocytes Receives: Drug: Azacitidine (AZA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukemia-free survival (LFS) time
Summary statistics for LFS time will be computed for all patients.
Measured: From the date of transplantation, assessed up to 1 year after transplantation.
Secondary outcomes (5)
overall survival (OS)
The method of Kaplan and Meier will be used to estimate the distribution of overall survival. Cox proportional hazards regression analysis will be used to model the association between overall survival and covariates of interest.
Measured: From the date of transplantation, assessed up to 1 year after transplantation.
Cumulative incidence of relapse (CIR)
Use the method of Gooley et al to estimate the cumulative incidence of relapse.
Measured: From the date of transplantation, assessed up to 1 year after transplantation.
Cumulative incidence of acute and chronic GVHD
Patients diagnosed with acute and chronic GVHD were recorded after DLI intervention.The definition of acute GVHD by national Institutes of Health (NIH) divides acute GVHD into classical acute GVHD and delayed acute GVHD
Measured: From the date of transplantation, assessed up to 1 year after transplantation.
NRM
The proportion of transplant-related deaths was recorded.
Measured: NRM
Incidence of toxicity of the regimen
Descriptive statistics will be used to summarize adverse events.
Measured: From the date of transplantation, assessed up to 1 year after transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start16 Jan 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 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 Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xianmin Song, M.D, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754540
- Sponsor's protocol ID
- SHSYXY-202405-AZA-DLI
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Azacitidine Combined with Donor Lymphocyte Infusion for Prevention of Recurrence After Haploid Hematopoietic Stem Cell Transplantation in High-risk Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06754540
- Acronym / sponsor ID
- SHSYXY-202405-AZA-DLI
- Conditions
- Acute Myeloid Leukemia (AML), Relapse
- Keywords
- azacitidine, donor lymphocyte infusion, HSCT, haploid, high-risk, AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 16 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Jan 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.
This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML.
At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 51 patients, and collect demographic data, medical history data, vital signs, physical examination and laboratory tests (blood routine; urine routine; liver and kidney function;Immune indicators: T cell subsets, Treg, etc.), pregnancy tests for female patients and other necessary auxiliary inspections.The time to start treatment is from the +90 to +180 days after high-risk AML haploid hematopoietic stem cell transplantation.
Detailed description
1.Basic solution: Azacitidine is administered subcutaneously at 32 mg/m2/d for five consecutive days, starting no earlier than day +90 after HSCT, then repeated every 28 days for a total of twelve cycles. DLI is administered after an interval of 48 hours. Prophylactic DLI is given in escalating doses every four to six weeks for a total of three to four doses.The initial dose of DLI for haploid transplant patients is 1×10^5 CD3+/kg receptor weight lymphocytes gradually increased to 5×10^5, 1×10^6 and (2~5)×10^6 CD3+ Lymphocytes.
- Start time of medication: +90 ~ +120 days after transplantation.
- Donor lymphocyte infusion was preceded by anti-anaphylaxis,such as promethazine and hormone therapy was prohibited.
- In the course of AZA and DLI intervention, other targeted drugs such as venetoclax or chemotherapy drugs can be added on the basis of AZA if MRD or MRD increase (>1log) ,DLI continues as planned.
2.Stop treatment: Occurrence of any of the following conditions:
- Life-threatening complications.
- Acute GVHD above II degree; chronic GVHD above moderate manifestations or overlapping syndrome; No chronic GVHD is observed if acute GVHD remission is observed after discontinuation for 1 to 2 months, then preventive treatment is started again .
- Hematologic recurrence, graft rejection or bone marrow donor chimerism <90%.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZA-DLI for acute myeloid leukemia post-transplant relapse preventiont | Experimental | Drug: Azacitidine (AZA)One arm,Azacitidine is administered subcutaneously at 32 mg/m2/d for five consecutive days, starting no earlier than day +90 after HSCT, then repeated every 28 days for a total of twelve cycles. DLI is administered after an interval of 48 hours. Prophylactic DLI is given in escalating doses every four to six weeks for a total of three to four doses.The initial dose of DLI for haploid transplant patients is 1×10^5 CD3+/kg receptor weight lymphocytes gradually increased to 5×10^5, 1×10^6 and (2~5)×10^6 CD3+ Lymphocytes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- -
- ≥18 years old and ≤70 years old, male or female;
- Patients with haploid peripheral blood stem cell transplantation of AML;
- All patients received BU based myeloablative conditionings;
- A diagnosis of high-risk AML is one of the following:
Key exclusion criteria (13 listed)
- Possible subjects who meet any of the following criteria will be excluded from the trial:
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 |
|---|---|---|
| Azacitidine (AZA)Azacitidine 32mg/m2 | Drug | AZA-DLI for acute myeloid leukemia post-transplant relapse preventiont |
Primary outcome
Leukemia-free survival (LFS) time
Time frame: From the date of transplantation, assessed up to 1 year after transplantation.
Summary statistics for LFS time will be computed for all patients.
5 secondary outcomes
overall survival (OS)
Time frame: From the date of transplantation, assessed up to 1 year after transplantation.
Cumulative incidence of relapse (CIR)
Time frame: From the date of transplantation, assessed up to 1 year after transplantation.
Cumulative incidence of acute and chronic GVHD
Time frame: From the date of transplantation, assessed up to 1 year after transplantation.
NRM
Time frame: NRM
Incidence of toxicity of the regimen
Time frame: From the date of transplantation, assessed up to 1 year after transplantation.
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 17 Jan 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.
Xianmin Song, M.D principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine (AZA) in people with Acute Myeloid Leukemia (AML) and Relapse, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 13 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: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Xianmin Song, M.D (021-63240090, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukemia-free survival (LFS) time (time frame: From the date of transplantation, assessed up to 1 year after transplantation.). 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 17 Jan 2025.