Interferon-α After DLI for the Prevention of Relapse

Study Overview
=================
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.

Official Title
-----------------
Interferon α After Prophylactic Donor Lymphocyte Infusion for the Relapse Prevention After Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Other: Interferon Alfa-2b


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interferon Alfa-2b<br>High-risk acute leukemia patients after hematopoietic stem cell transplantation receive interferon Alfa-2b after prophylactic DLI | Other: Interferon Alfa-2b<br>* High-risk acute leukemia patients receive prophylactic DLI at day 30-60 after hematopoietic stem cell transplantation,they received interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) . Interferon treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.<br>* Other names: INF α-2b;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukemia free survival | Number of participants survived without leukemia at three years | Participants will be followed for an expected average of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interferon Alfa-2b, Relapse, Donor lymphocyte infusion