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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematological Neoplasms, Recurrence

Intervention / Treatment
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* Drug: Peg interferon alfa-2b


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peg interferon alfa-2b<br>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<br>* 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.<br>* Other names: PEG INTRON®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 90 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematological Neoplasms, recurrence, Hematopoietic Stem Cell Transplantation, peginterferon alfa-2b, Graft vs Host Disease