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

NCT02634294 | Completed Phase 2

• 1 other identifier: Shanghai1st
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Neoplasms; Recurrence

Keywords

Hematological Neoplasms; recurrence; Hematopoietic Stem Cell Transplantation; peginterferon alfa-2b; Graft vs Host Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• overall survival after relapsing

  one year

• disease free survival after relapsing

  one year

Study Arms (1)

Peg interferon alfa-2b

EXPERIMENTAL

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

Interventions

Peg interferon alfa-2b DRUG

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.

Also known as: PEG INTRON®

Peg interferon alfa-2b

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao Tong University Affilated First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (2)

• 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.

  PMID: 16939523 BACKGROUND

• 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.

  PMID: 25460355 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms; Recurrence; Graft vs Host Disease

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Chun Wang, M.D., Ph.D.

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, department of Hematology

Study Record Dates

• First Submitted: December 5, 2015
• First Posted: December 18, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)