NCT06802718RecruitingPhase 3
Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 21 Dec 2024
- Start date
- 1 Jan 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06802718
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 96
- From 1 Jan 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients strongly demanding transplantation, and with indications for transplantation but not eligible for transplantation.
- Previous hyperthyroidism or hypothyroidism.
Other illness
- Uncontrolled active infection.
Other
- Acute promyelocytic leukemia (APL).
- AML with normal karyotype and bZIP intramolecular mutations in CEBPA.
- ≥ CR2 status.
- Severe organ dysfunction.
- Pregnancy.
- Unwillingness to undergo interferon treatment.
- Participation in other clinical trials within one month.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.