Interferon-α After DLI for the Prevention of Relapse

Phase 1

• Conditions: Leukemia
• Interventions: Other: Interferon Alfa-2b

• Registration Number: NCT02568241
• Lead Sponsor: Peking University People's Hospital

Brief Summary

This study aimed to evaluate the efficacy of interferon α after prophylactic donor lymphocyte infusion (DLI) among high-risk acute leukemia patients undergone unmanipulated blood and marrow transplantation. Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for high-risk acute leukemia (AL). However, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.Prophylactic DLI can decrease the risk of relapse of high-risk AL patients. Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential value for high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b after prophylactic DLI following hematopoietic stem cell transplantation in patients with high-risk AL can further reduce relapse rate and improve leukemia-free survival.

Detailed Description

High risk acute leukemia patients (except t(9;22)(q34; q11) cytogenetic abnormalities.) received interferon α-2b after prophylactic DLI at day 30-60 after unmanipulated blood and marrow transplantation. The end points were safety, leukemia-free survival, and immunologic response. Following time is 12 months.

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Study Start: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29
• Primary Completion: 2017-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients who had high-risk acute leukemia after hematopoietic stem cell transplantation

Exclusion Criteria

• Patients with t(9;22)(q34; q11) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure, or relapse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interferon Alfa-2b	Interferon Alfa-2b	High-risk acute leukemia patients after hematopoietic stem cell transplantation receive interferon Alfa-2b after prophylactic DLI

Primary Outcome Measures

Name	Time	Method
Leukemia free survival	Participants will be followed for an expected average of 3 years	Number of participants survived without leukemia at three years

Trial Locations

Locations (1)

Peking University Institute of Hematology,Beijing; 🇨🇳 Beijing, Beijing, China