A phase I / II study to evaluate the effect of pegylated-Interferon-2alpha on overall survival in patients with relapsed haematological malignancy after allogeneic haematopoietic progenitor cell transplantation (HPCT)

Royal Brisbane and Womens Hospital0 个研究点目标入组 30 人开始时间: 2012年7月6日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•*Patients with relapse of their primary disease after allogeneic HPCT (either sibling or VUD donors).
•*Age greater than or equal to 18 years and less than 70 years
•*Eastern Cooperative Oncology Group (ECOG) performance status <3 (Karnofsky >50%)
•*Off immune suppression:
•Patients are allowed to continue on prednisolone (or equivalent) at doses <0.5mg/kg/day.
•Patients must have ceased Cyclosporine (CSA), Tacrolimus (Tacro), Mycophenolate Mofetil (MMF) and / or all other immunosuppressants
•*Absence of active significant graft versus host disease off immunosupression defined by less than grade 2 acute graft vesus host disease and or progressive or extensive stage chronic graft versus host disease.
•*Adequate organ function for FLAG chemotherapy:
•Total Bilirubin less than or equal to 30umol/L
•Creatinine clearance less than or equal to 50ml/min/1.73m^2 for patients with creatinine levels above

•*Inadequate organ function for FLAG chemotherapy (if in haematological relapse):
•Total Bilirubin >30umol/L
•Creatinine Clearance < 50ml/min/1.73m^2 for patients with creatinine levels above ULN
•*Active acute (grade II-IV) or progressive and / or extensive stage chronic GVHD requiring immune suppression with prednisone (or equivalent) at doses >0.5mg/kg/day or ongoing therapy with other immunosuppressant medications including calcineurin inhibitors (cyclosporine, Tacrolimus) and MMF.
•*Patients receiving any other investigational agents
•*Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, uncontrolled hypertension or heart failure, uncontrolled diabetes, uncontrolled autoimmune disease (especially thyroid), uncontrolled COPD, uncontrolled depression, epilepsy and social situations that would limit compliance with study requirements.
•*Known HIV infection.
•*Pregnant or breastfeeding, or patient with reproductive potential who is not willing to use adequate contraceptive precautions in the judgement of the Investigator. Adequate contraception is defined as a double-barrier method, i.e. using at least 2 methods of contraception e.g. 2 actual barrier methods or 1 actual barrier method and 1 hormonal method.
•*Donor is an identical twin (i.e. syngeneic)
•*History of allergic or grade IV reactions to interferon, including known allergies to E coli-derived products eg. G-CSF.

发起方

Royal Brisbane and Womens Hospital