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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT02634294

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Neoplasms Recurrence	Drug: Peg interferon alfa-2b	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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®

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

Other Names:

PEG INTRON®

Outcome Measures

Primary Outcome Measures

response rate of Peg interferon alpha-2b [90 days]
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 [one year]
the percentage of patients still alive after 1 year
disease free survival after relapsing [one year]
the percentage of patients still alive and disease free after 1 year

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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