Interferon-α After DLI for the Prevention of Relapse

NCT02568241 | Unknown Phase 1 DMC

• 1 other identifier: 2015-10
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

Interferon Alfa-2b; Relapse; Donor lymphocyte infusion

Outcome Measures

Primary Outcomes (1)

• Leukemia free survival

  Number of participants survived without leukemia at three years

  Participants will be followed for an expected average of 3 years

Study Arms (1)

interferon Alfa-2b

EXPERIMENTAL

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

Other: Interferon Alfa-2b

Interventions

Interferon Alfa-2b OTHER

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.

Also known as: INF α-2b

interferon Alfa-2b

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients who had high-risk acute leukemia after hematopoietic stem cell transplantation

You may not qualify if:

• Patients with t(9;22)(q34; q11) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure, or relapse

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University Institute of Hematology,Beijing

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Leukemia; Recurrence

Interventions

Interferon alpha-2

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Xiao-Jun HUANG, MD

  Peking University Institute of Hematology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Dong MO, MD

CONTACT

86-10-88326001; mxd453@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 5, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2020
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

CN (1)