Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia

NCT06802718 | Recruiting Phase 3

• 1 other identifier: 2023PHD001-001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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, 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

Outcome Measures

Primary Outcomes (1)

• 6-month negative conversion of MRD

  MFC-MRD or RT-PCR genes (AML1-ETO, NPM1, and CBFb-MYH11) transition from positive to negative.

  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

  Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.

• EFS

  Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.

• OS

  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

  Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.

Study Arms (2)

Interferon Group

EXPERIMENTAL

Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.

Drug: Interferon

Control Group

NO INTERVENTION

Observational follow-up without receiving any maintenance treatment.

Interventions

Interferon DRUG

Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.

Interferon Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Interferons

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Feifei Tang, Prof

CONTACT

13581671687; bjmugirl@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: January 31, 2025
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

CN (1)