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

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ClinicalTrials.gov Identifier: NCT02568241
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang, 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.

Condition or disease Intervention/treatment Phase
Leukemia Other: Interferon Alfa-2b Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Interferon α After Prophylactic Donor Lymphocyte Infusion for the Relapse Prevention After Hematopoietic Stem Cell Transplantation
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: interferon Alfa-2b
High-risk acute leukemia patients after hematopoietic stem cell transplantation receive interferon Alfa-2b after prophylactic DLI
Other: Interferon Alfa-2b
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.
Other Name: INF α-2b




Primary Outcome Measures :
  1. Leukemia free survival [ Time Frame: Participants will be followed for an expected average of 3 years ]
    Number of participants survived without leukemia at three years



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568241


Contacts
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Contact: Xiao-Dong MO, MD 86-10-88326001 mxd453@163.com

Locations
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China, Beijing
Peking University Institute of Hematology,Beijing Recruiting
Beijing, Beijing, China, 100044
Contact: Xiao-Dong Mo       mxd453@163.com   
Principal Investigator: Xiao-Jun Huang, MD         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiao-Jun HUANG, MD Peking University Institute of Hematology
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Responsible Party: Xiaojun Huang, Principal Investigator, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02568241    
Other Study ID Numbers: 2015-10
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Keywords provided by Xiaojun Huang, Peking University People's Hospital:
Interferon Alfa-2b
Relapse
Donor lymphocyte infusion
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Interferons
Interferon-alpha
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs