Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
NCT ID: NCT06802718
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
96 participants
INTERVENTIONAL
2023-01-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interferon Group
Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.
Interferon
Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.
Control Group
Observational follow-up without receiving any maintenance treatment.
No interventions assigned to this group
Interventions
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Interferon
Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Pregnancy.
* Unwillingness to undergo interferon treatment.
* Previous hyperthyroidism or hypothyroidism.
* Participation in other clinical trials within one month.
18 Years
70 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Xiao-Jun Huang
Principal Investigator
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023PHD001-001
Identifier Type: -
Identifier Source: org_study_id
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