Using Interferon-alpha to maintain remission in favorable-risk Acute Myeloid Leukemia

A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia

This study is testing if a treatment called Interferon-alpha can help keep patients with favorable-risk Acute Myeloid Leukemia in remission after they’ve completed chemotherapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06802718 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Interferon-alpha as a maintenance therapy for patients with favorable-risk Acute Myeloid Leukemia (AML) who have achieved complete remission after standard chemotherapy. It is a prospective, randomized, controlled trial that aims to evaluate the efficacy and safety of this treatment by monitoring minimal residual disease (MRD) and overall survival rates. The primary endpoint is the negative conversion of MRD at 6 months, while secondary endpoints include relapse rates and event-free survival over two years. The study seeks to identify effective strategies to prevent relapse and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed favorable-risk AML who have achieved complete remission after chemotherapy.

Not a fit: Patients with acute promyelocytic leukemia or those with certain genetic mutations in their AML may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and reduce relapse in patients with favorable-risk AML.

How similar studies have performed: While the use of Interferon-alpha in this context is being explored, similar approaches in other studies have shown promise in improving outcomes for AML patients.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Pregnancy.
* Unwillingness to undergo interferon treatment.
* Previous hyperthyroidism or hypothyroidism.
* Participation in other clinical trials within one month.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Feifei Tang, Prof

Conditions: Acute Myeloid Leukemia