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

Primary Purpose

Hematological Neoplasms, Recurrence

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Peg interferon alfa-2b
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Neoplasms focused on measuring Hematological Neoplasms, recurrence, Hematopoietic Stem Cell Transplantation, peginterferon alfa-2b, Graft vs Host Disease

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Jiao Tong University Affilated First People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peg interferon alfa-2b

Arm Description

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.

Outcomes

Primary Outcome Measures

response rate of Peg interferon alpha-2b
the percentage of patients acquiring complete remission and partial remission to Peg interferon alpha-2b in 90 days after treatment

Secondary Outcome Measures

overall survival after relapsing
the percentage of patients still alive after 1 year
disease free survival after relapsing
the percentage of patients still alive and disease free after 1 year

Full Information

First Posted
December 5, 2015
Last Updated
March 15, 2023
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02634294
Brief Title
Peg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT
Official Title
Induction of Graft Versus Tumor Effect of Pegylated Interferon Alpha-2b for Patients With Relapsed Hematological Malignancies After Allogeneic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Neoplasms, Recurrence
Keywords
Hematological Neoplasms, recurrence, Hematopoietic Stem Cell Transplantation, peginterferon alfa-2b, Graft vs Host Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peg interferon alfa-2b
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Peg interferon alfa-2b
Other Intervention Name(s)
PEG INTRON®
Intervention Description
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.
Primary Outcome Measure Information:
Title
response rate of Peg interferon alpha-2b
Description
the percentage of patients acquiring complete remission and partial remission to Peg interferon alpha-2b in 90 days after treatment
Time Frame
90 days
Secondary Outcome Measure Information:
Title
overall survival after relapsing
Description
the percentage of patients still alive after 1 year
Time Frame
one year
Title
disease free survival after relapsing
Description
the percentage of patients still alive and disease free after 1 year
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 14-60 years, male or female Allo-HSCT recipients with malignant hematological diseases Disease relapse after allo-HSCT, including hematological relapse, molecular relapse Able to provide written informed consent and to comply with all study procedures Exclusion Criteria: Pregnant or nursing woman Cardiac ejection factor < normal lower limit Active acute or chronic GVHD with immunosuppressant treatment Known hypersensitivity or allergy to interferon Patient might develop serious complications according to investigator's experiences Patient is undergoing other experimental medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Wang, M.D., Ph.D.
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiao Tong University Affilated First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant date available before publication
Citations:
PubMed Identifier
16939523
Citation
Gupta S, Jen J, Kolz K, Cutler D. Dose selection and population pharmacokinetics of PEG-Intron in patients with chronic myelogenous leukaemia. Br J Clin Pharmacol. 2007 Mar;63(3):292-9. doi: 10.1111/j.1365-2125.2006.02757.x. Epub 2006 Aug 30.
Results Reference
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PubMed Identifier
25460355
Citation
Bejanyan N, Weisdorf DJ, Logan BR, Wang HL, Devine SM, de Lima M, Bunjes DW, Zhang MJ. Survival of patients with acute myeloid leukemia relapsing after allogeneic hematopoietic cell transplantation: a center for international blood and marrow transplant research study. Biol Blood Marrow Transplant. 2015 Mar;21(3):454-9. doi: 10.1016/j.bbmt.2014.11.007. Epub 2014 Nov 15.
Results Reference
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Peg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT

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