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

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634294
• Other study ID #: Shanghai1st
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2015
• Est. completion date: December 2021

Study information

• Verified date: March 2023
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Neoplasms
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affilated First People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival after relapsing	the percentage of patients still alive after 1 year	one year
Secondary	disease free survival after relapsing	the percentage of patients still alive and disease free after 1 year	one year