Peg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT

March 15, 2023 updated by: Chun Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Induction of Graft Versus Tumor Effect of Pegylated Interferon Alpha-2b for Patients With Relapsed Hematological Malignancies After Allogeneic Stem Cell Transplantation

Aim: to observe the graft versus tumor effect of Pegylated Interferonα-2b in patients with hematological malignancies relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT) Patients: patients relapsed after alloHSCT, men and women aged 14-60 years, without vital organ dysfunction or ongoing graft-verus-host disease (GVHD).

Number of subjects: 50, Single center, one group, prospective. Drug: pegylated interferon alpha-2b (Peg Intron®; Schering-Plough) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible patients were age 14 to 60 years with molecular, hematological or radiography relapsed hematological malignancies post allogeneic hematopoietic stem cell transplantation.

Molecular relapse was defined as reappearance or 1 log increase of molecular markers or decreasing donor chimerism by more than 5%; Hematological relapse was defined as reappearance of blast in bone marrow smear by more than 5%; radiography relapse was defined as enlargement of lymph nodes by more than 25% or infiltration of tumor cells in other sites.

Patients were excluded if they need immunosuppressant treatment for ongoing grade II～IV acute GVHD or moderate to severe chronic GVHD.

Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute GVHD, or no response to treatment after 8 doses of treatments. Patients were followed up every week. Physical exams and blood tests including complete blood count (CBC), chemical were performed every week. Disease status evaluation was performed every month.

Number of subjects: 50 Single center, one group, prospective.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai Jiao Tong University Affilated First People's Hospital

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

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 14-60 years, male or female
  2. Allo-HSCT recipients with malignant hematological diseases
  3. Disease relapse after allo-HSCT, including hematological relapse, molecular relapse
  4. Able to provide written informed consent and to comply with all study procedures

Exclusion Criteria:

  1. Pregnant or nursing woman
  2. Cardiac ejection factor < normal lower limit
  3. Active acute or chronic GVHD with immunosuppressant treatment
  4. Known hypersensitivity or allergy to interferon
  5. Patient might develop serious complications according to investigator's experiences
  6. Patient is undergoing other experimental medication

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peg interferon alfa-2b
Pegylated Interferon α-2b (PEG INTRON®) , 1~1.5μg/kg qw, subcutaneous injection, 1 to 12 months, until occurrence of grade II or higher grade of acute graft versus host disease, or no response to treatment after 8 doses of treatments.
Drug: Peg interferon alfa-2b
Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute graft versus host disease, or no response to treatment after 8 doses of treatments.
Other Names:
  • PEG INTRON®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate of Peg interferon alpha-2b
Time Frame: 90 days
the percentage of patients acquiring complete remission and partial remission to Peg interferon alpha-2b in 90 days after treatment
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival after relapsing
Time Frame: one year
the percentage of patients still alive after 1 year
one year
disease free survival after relapsing
Time Frame: one year
the percentage of patients still alive and disease free after 1 year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Chun Wang, M.D., Ph.D., Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2015

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

December 5, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shanghai1st

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant date available before publication

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.

Clinical Trials on Recurrence

Clinical Trials on Peg interferon alfa-2b

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe