Acute Myeloid LeukemiaPhase 3NCT06802718
Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
A Phase 3 study testing Interferon in people with Acute Myeloid Leukemia, run by Peking University People's Hospital at 1 site in China.
Trial summary
This research focuses on a prospective, randomized, controlled trial of "Interferon-alpha as maintenance therapy for favorable-risk acute myeloid leukemia." By fully utilizing prospective, randomized, controlled clinical trial and studying the negative conversion of MRD and the survival of favorable-risk AML patients… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Interferon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Dec 2026
- Phase
- Phase 3
- 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
- Aged 18-70 years old (including 18 and 70 years old) with newly diagnosed favorable-risk AML (2022 ELN risk group classification).
- Achieved CR1 after 1-2 cycles of standard chemotherapy.
- Completed 4-6 cycles of consolidation chemotherapy (including at least 2 cycles of high-dose Cytarabine HDAC regimem).
- At the end of consolidation treatment, bone marrow examination confirmed in CR1, flow cytometry MRD negative, but molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by > 3 log, but still detectable.
- Performance status score of 0-2 (ECOG).
- Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal.
- Kidney function: Creatinine ≤ 1.5 times the upper limit of normal.
Who cannot join
- Acute promyelocytic leukemia (APL).
- AML with normal karyotype and bZIP intramolecular mutations in CEBPA.
- ≥ CR2 status.
- Patients strongly demanding transplantation, and with indications for transplantation but not eligible for transplantation.
- Uncontrolled active infection.
- Severe organ dysfunction.
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- Pregnancy.
- Unwillingness to undergo interferon treatment.
- Previous hyperthyroidism or hypothyroidism.
- Participation in other clinical trials within one month.
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
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Feifei Tang, 13581671687, bjmugirl@163.com
About this study
Official title: A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
This research focuses on a prospective, randomized, controlled trial of "Interferon-alpha as maintenance therapy for favorable-risk acute myeloid leukemia." By fully utilizing prospective, randomized, controlled clinical trial and studying the negative conversion of MRD and the survival of favorable-risk AML patients, it aims to explore the efficacy and safety of Interferon-alpha in the maintenance treatment of favorable-risk AML and identify effective measures to prevent relapse, thereby improving the survival of favorable-risk AML patients. The primary endpoint is the negative conversion of MRD at 6 months. The secondary endpoints include the 2-year cumulative incidence of relapse, 2-year event-free survival (EFS), 2-year overall survival (OS), and safety.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Interferon
- 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.
InterferonDrug
Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Interferon Group | Experimental | Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months. Receives: Drug: Interferon |
| Control Group | No intervention | Observational follow-up without receiving any maintenance treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month negative conversion of MRD
MFC-MRD or RT-PCR genes (AML1-ETO, NPM1, and CBFb-MYH11) transition from positive to negative.
Measured: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
Secondary outcomes (4)
CIR
The number of patients with relapse calculated from the randomization time to the last follow-up time.
Measured: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
EFS
Events include treatment failure (MRD positivity or molecular progression), relapse, or death from any cause.
Measured: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
OS
calculated from randomization time to the time of death or the last follow-up time.
Measured: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
Treatment-related Safety Indicators
Mainly include hematologic toxicity and liver toxicity.
Measured: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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 Peking University People's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802718
- Sponsor's protocol ID
- 2023PHD001-001
- Status last verified
- Jan 2025
- First submitted
- 21 Dec 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06802718
- Acronym / sponsor ID
- 2023PHD001-001
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 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 research focuses on a prospective, randomized, controlled trial of "Interferon-alpha as maintenance therapy for favorable-risk acute myeloid leukemia." By fully utilizing prospective, randomized, controlled clinical trial and studying the negative conversion of MRD and the survival of favorable-risk AML patients, it aims to explore the efficacy and safety of Interferon-alpha in the maintenance treatment of favorable-risk AML and identify effective measures to prevent relapse, thereby improving the survival of favorable-risk AML patients. The primary endpoint is the negative conversion of MRD at 6 months. The secondary endpoints include the 2-year cumulative incidence of relapse, 2-year event-free survival (EFS), 2-year overall survival (OS), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon Group | Experimental | Drug: InterferonPolyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months. |
| Control Group | No intervention | –Observational follow-up without receiving any maintenance treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-70 years old (including 18 and 70 years old) with newly diagnosed favorable-risk AML (2022 ELN risk group classification).
- Achieved CR1 after 1-2 cycles of standard chemotherapy.
- Completed 4-6 cycles of consolidation chemotherapy (including at least 2 cycles of high-dose Cytarabine HDAC regimem).
- At the end of consolidation treatment, bone marrow examination confirmed in CR1, flow cytometry MRD negative, but molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by > 3 log, but still detectable.
- Performance status score of 0-2 (ECOG).
Key exclusion criteria (10 listed)
- Acute promyelocytic leukemia (APL).
- AML with normal karyotype and bZIP intramolecular mutations in CEBPA.
- ≥ CR2 status.
- Patients strongly demanding transplantation, and with indications for transplantation but not eligible for transplantation.
- Uncontrolled active infection.
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 |
|---|---|---|
| InterferonPolyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months. | Drug | Interferon Group |
Primary outcome
6-month negative conversion of MRD
Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
MFC-MRD or RT-PCR genes (AML1-ETO, NPM1, and CBFb-MYH11) transition from positive to negative.
4 secondary outcomes
CIR
Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
EFS
Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
OS
Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
Treatment-related Safety Indicators
Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
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 31 Jan 2025.
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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 Phase 3 study testing Interferon in people with Acute Myeloid Leukemia, 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 7 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 31 Jan 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Feifei Tang, Prof (13581671687, bjmugirl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month negative conversion of MRD (time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.). 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 31 Jan 2025.