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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

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

NCT ID

NCT02568241

First Posted

September 30, 2015

Last Updated

September 28, 2016

Sponsor

Peking University People's Hospital

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

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

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

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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