Acute Myeloid LeukemiaPhase 2NCT07449286
IFN-α in Relapse Prevention.
A Phase 2 study testing IFN-α in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Peking University People's Hospital at 1 site in China.
Trial summary
To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- IFN-α
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Myelodysplastic syndrome (MDS) diagnosed according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemia (2022ICC) criteria, acute myeloid leukemia (AML) with TP53 mutation (unrestricted remission status), minimal residual disease (MRD) monitored by flow cytometry within 2 months after receiving the first allogeneic hematopoietic stem cell transplantation Negative patients
- Male or female, aged 12-65 years
- Karnofsky score >60, estimated survival time >3 months
- No history of severe graft-versus-host disease (GVHD), uncontrolled
- GVHD, or severe systemic organ dysfunction:
- Absolute neutrophil count (ANC) greater than 0.5×109/L
Show all 9Show fewer
- Creatinine < 1.5mg/dL
- Cardiac ejection index >55%
- Signed informed consent.
Who cannot join
- severe cardiac, renal, or liver dysfunction
- combined with other malignant tumors requiring treatment
- inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness
- patients who are unable to complete the necessary treatment plan and follow-up observation
- patients with severe acute anaphylaxis
- clinically uncontrolled severe life-threatening infections
- patients enrolled in other clinical trials
- other reasons considered by the investigator to be inappropriate for clinical trial participants.
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
Peking University People's Hospital, Peking University Institute of Hematology
Beijing, Beijing Municipality, 100044
Yu Wang, 010-88326000, ywyw3172@sina.com
About this study
Official title: A Multicenter Study on the Effect of Interferon-α in Patients With TP53-Mutant Myeloid Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation
To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML/MDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- IFN-α
- Keywords
- IFN-α, Preventing relapse, allo-HSCT
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFN-αDrug
Leukemia-associated immunophenotyping (LAIPs) was performed by flow cytometry at +1 month and
- 2 month after HSCT. If MRD was negative on two consecutive flow cytometry assays, interferon- α prophylaxis was initiated on day +75 after transplantation, and cyclosporine was tapered on day
- 100 after transplantation. The dose of interferon- α was 3 million units/time, subcutaneously injected twice a week. Cycles were given every 4 weeks until hematologic relapse or up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| IFN-α application in TP53+ myeloid malignancy | Experimental | Not described Receives: Drug: IFN-α |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of relapse
Disease relapse was defined as blasts ≥ 5% post transplantation
Measured: 1 year post HSCT
Secondary outcomes (5)
The incidence of positive minimal residual disease post allo-HSCT
Positive MRD was defined as leukemia-associated immunophenotyping (LAIPs) by flow cytometry
Measured: 1 year post HSCT
The incidence of acute and chronic graft versus host disease (GvHD)
The severity of acute GvHD (aGvHD) and chronic GvHD (cGvHD) was evaluated according to standard criteria.
Measured: aGvHD within 100 days and cCvHD within 1 year
The incidence of non-relapse mortality
The incidence of non-relapse mortality
Measured: 1 year post HSCT
The probability of progression free survival
Survival without disease progression
Measured: 1 year post HSCT
The probability of overall survival (OS)
OS was defined as the time from transplantation to death from any cause or to the last follow-up.
Measured: 1 year post HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aerospace Medical Center, LU DAOPEI MEDICAL, Nanfang Hospital, Southern Medical University, Zhejiang University
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiaojun Huang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449286
- Sponsor's protocol ID
- IFN-α in relapse prevention.
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the Effect of Interferon-α in Patients With TP53-Mutant Myeloid Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07449286
- Acronym / sponsor ID
- IFN-α in relapse prevention.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- IFN-α, Preventing relapse, allo-HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Aerospace Medical Center, LU DAOPEI MEDICAL, Nanfang Hospital, Southern Medical University, Zhejiang University
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Mar 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.
To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML/MDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IFN-α application in TP53+ myeloid malignancy | Experimental | Drug: IFN-α |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Myelodysplastic syndrome (MDS) diagnosed according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemia (2022ICC) criteria, acute myeloid leukemia (AML) with TP53 mutation (unrestricted remission status), minimal residual disease (MRD) monitored by flow cytometry within 2 months after receiving the first allogeneic hematopoietic stem cell transplantation Negative patients
- Male or female, aged 12-65 years
- Karnofsky score >60, estimated survival time >3 months
- No history of severe graft-versus-host disease (GVHD), uncontrolled
- Signed informed consent.
Key exclusion criteria (8 listed)
- severe cardiac, renal, or liver dysfunction
- combined with other malignant tumors requiring treatment
- inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness
- patients who are unable to complete the necessary treatment plan and follow-up observation
- patients with severe acute anaphylaxis
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 |
|---|---|---|
| IFN-αLeukemia-associated immunophenotyping (LAIPs) was performed by flow cytometry at +1 month and * 2 month after HSCT. If MRD was negative on two consecutive flow cytometry assays, interferon- α prophylaxis was initiated on day +75 after transplantation, and cyclosporine was tapered on day * 100 after transplantation. The dose of interferon- α was 3 million units/time, subcutaneously injected twice a week. Cycles were given every 4 weeks until hematologic relapse or up to 6 cycles. | Drug | IFN-α application in TP53+ myeloid malignancy |
Primary outcome
The incidence of relapse
Time frame: 1 year post HSCT
Disease relapse was defined as blasts ≥ 5% post transplantation
5 secondary outcomes
The incidence of positive minimal residual disease post allo-HSCT
Time frame: 1 year post HSCT
The incidence of acute and chronic graft versus host disease (GvHD)
Time frame: aGvHD within 100 days and cCvHD within 1 year
The incidence of non-relapse mortality
Time frame: 1 year post HSCT
The probability of progression free survival
Time frame: 1 year post HSCT
The probability of overall survival (OS)
Time frame: 1 year post HSCT
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 4 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
RecruitingPhase 2
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
Recruiting
Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies
Myelodysplastic Syndromes (MDS), Leukemia Acute Myeloid - AML
RecruitingPhase 2
Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 1/2
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
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.
Xiaojun Huang principal investigator
Peking University People's Hospital
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 IFN-α in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Peking University People's Hospital 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 9 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: opening soon, as of the sponsor's last update on 4 Mar 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.
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 Yu Wang (010-88326000, ywyw3172@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of relapse (time frame: 1 year post HSCT). 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 4 Mar 2026.