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Interferon-α After DLI for the Prevention of Relapse (IDPR-HSCT)

Primary Purpose

Leukemia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Interferon Alfa-2b
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia focused on measuring Interferon Alfa-2b, Relapse, Donor lymphocyte infusion

Eligibility Criteria

2 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Institute of Hematology,BeijingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

interferon Alfa-2b

Arm Description

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

Outcomes

Primary Outcome Measures

Leukemia free survival
Number of participants survived without leukemia at three years

Secondary Outcome Measures

Full Information

First Posted
September 30, 2015
Last Updated
September 28, 2016
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02568241
Brief Title
Interferon-α After DLI for the Prevention of Relapse
Acronym
IDPR-HSCT
Official Title
Interferon α After Prophylactic Donor Lymphocyte Infusion for the Relapse Prevention After Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
Interferon Alfa-2b, Relapse, Donor lymphocyte infusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interferon Alfa-2b
Arm Type
Experimental
Arm Description
High-risk acute leukemia patients after hematopoietic stem cell transplantation receive interferon Alfa-2b after prophylactic DLI
Intervention Type
Other
Intervention Name(s)
Interferon Alfa-2b
Other Intervention Name(s)
INF α-2b
Intervention Description
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.
Primary Outcome Measure Information:
Title
Leukemia free survival
Description
Number of participants survived without leukemia at three years
Time Frame
Participants will be followed for an expected average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Dong MO, MD
Phone
86-10-88326001
Email
mxd453@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Jun HUANG, MD
Organizational Affiliation
Peking University Institute of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Institute of Hematology,Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-Dong Mo
Email
mxd453@163.com
First Name & Middle Initial & Last Name & Degree
Xiao-Jun Huang, MD

12. IPD Sharing Statement

Learn more about this trial

Interferon-α After DLI for the Prevention of Relapse

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