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Trial record 62 of 1269 for:    IFNA2

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

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ClinicalTrials.gov Identifier: NCT02634294
Recruitment Status : Active, not recruiting
First Posted : December 18, 2015
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Chun Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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 : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


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 Name: PEG INTRON®




Primary Outcome Measures :
  1. response rate of Peg interferon alpha-2b [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. overall survival after relapsing [ Time Frame: one year ]
  2. disease prognostic factors of overall survival after alloHSCT relapse [ Time Frame: one year ]
  3. disease free survival after relapsing [ Time Frame: one year ]


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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634294


Locations
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China, Shanghai
Shanghai Jiao Tong University Affilated First People's Hospital
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Chun Wang, M.D., Ph.D. Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications:
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Responsible Party: Chun Wang, Director, department of Hematology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02634294     History of Changes
Other Study ID Numbers: Shanghai1st
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant date available before publication

Keywords provided by Chun Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Hematological Neoplasms
recurrence
Hematopoietic Stem Cell Transplantation
peginterferon alfa-2b
Graft vs Host Disease

Additional relevant MeSH terms:
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Interferon alpha-2
Interferon-alpha
Recurrence
Hematologic Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms by Site
Neoplasms
Hematologic Diseases
Interferons
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs