Clinical trial NCT02634294: Peg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hematological Neoplasms
Recurrence
Keywords: Hematological Neoplasms
recurrence
Hematopoietic Stem Cell Transplantation
peginterferon alfa-2b
Graft vs Host Disease
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: response rate of Peg interferon alpha-2b
timeFrame: 90 days
Secondary outcomes:
measure: overall survival after relapsing
timeFrame: one year
measure: disease free survival after relapsing
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affilated First People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Chun Wang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.