- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02568241
Interferon-α After DLI for the Prevention of Relapse (IDPR-HSCT)
September 28, 2016 updated by: Xiaojun Huang, Peking University People's Hospital
Interferon α After Prophylactic Donor Lymphocyte Infusion for the Relapse Prevention After Hematopoietic Stem Cell Transplantation
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
42
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiao-Dong MO, MD
- Phone Number: 86-10-88326001
- Email: mxd453@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Recruiting
- Peking University Institute of Hematology,Beijing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: interferon Alfa-2b
High-risk acute leukemia patients after hematopoietic stem cell transplantation receive interferon Alfa-2b after prophylactic DLI
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Participants will be followed for an expected average of 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiao-Jun Huang, MD, Peking University Institute of Hematology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
September 30, 2015
First Submitted That Met QC Criteria
October 2, 2015
First Posted (Estimate)
October 5, 2015
Study Record Updates
Last Update Posted (Estimate)
September 29, 2016
Last Update Submitted That Met QC Criteria
September 28, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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