A phase II study of humanized anti-IL-6 receptor antibody Tocilizumab (TCZ) to prevent development of acute graft versus host disease (GVHD) post Human Leuckocyte Antigen(HLA)-mismatched allogeneic haematopoietic progenitor cell transplantation (HPCT)

Royal Brisbane and Women's Hospital0 个研究点目标入组 18 人开始时间: 2014年2月27日最近更新: 2020年1月13日

试验速览

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•Patients undertaking a T cell-replete HLA-mismatched allogeneic HPCT using either myeloablative or reduced intensity conditioning
•Aged greater than or equal to 18 and less than 65 years
•Life expectancy of greater than 3 months
•Eastern Cooperative Oncology Group (ECOG) performance status less than 2 (Karnofsky greater than 50%)
•Adequate organ function for allogeneic stem cell transplantation as per Institutional guidelines
•1 or 2 Antigen HLA-mismatched sibling donor by typing at HLA-A, B, C and DRB1 and DQ loci. Only 1 antigen mismatch is allowed at HLA-A, B, C or DRB1, with / without a further mismatch at HLA-DQ.
•1 or 2 HLA- matched volunteer unrelated donor (VUD) by typing at HLA-A, B, C, DRB1 and DQ loci. Only 1 antigen mismatch is allowed at HLA-A, B, C or DRB1, with / without a further mismatch at HLA-DQ.
•Able and willing to provide written informed consent

•Inadequate organ function for allogeneic stem cell transplantation as per Institutional guidelines.
•Patients receiving any other investigational agents.
•Patients with a past history of solid tumours within prior 2 years (excluding completely excised cutaneous BCC and SCC).
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness / social situations that would limit compliance with study requirements.
•Known HIV, HCV or active HBV infection. Patients who are HepBcAb positive but HepBsAg negative (i.e. have had past HepB exposure) should receive lamivudine up to at least day 100 after HPCT.
•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.
•Patients with a past history of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal (GI) perforation.
•Donor is an identical twin (i.e. syngeneic)
•History of allergic reactions attributed to compounds of similar chemical or biologic composition as TCZ, including known allergies to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.

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