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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b

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