se of Tocilizumab (TCZ) to prevent acute graft versus host disease (GVHD)

Phase 1

Recruiting

• Conditions: Acute graft versus host disease (GVHD) post HLA-matched allogeneic haematopoietic progenitor cell transplantation (HPCT); Cancer - Leukaemia - Acute leukaemia; Cancer - Leukaemia - Chronic leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

• Registration Number: ACTRN12612000726853
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Patients undertaking a T cell-replete HLA-matched allogeneic HPCT using either myeloblative or reduced intensity conditioning, life expectancy of greater than 3 months, ECOG < 2, Total bilirubin less than 30, Serum transaminases (AST/ALT) less than 3.0 x ULN, creatinine clearance greater than or equal to 50mL/min/1.73m^2, LVEF greater than or equal to 40 %, Pulmonary diffusion capacity greater than or equal to 40 %, HLA-matched sibling donor or HLA-matched volunteer unrelated donor.

Exclusion Criteria

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 and HBV infection, pregnant or breastfeeding, or patient with reproductive potential who is not willing to use adequate contraceptive precautions in the judgement of the Investigator, 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 compositions as TCZ, including known allergies to Chinese hamster ovary cell products or other recombinant human or humanised antibodies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of grade II-IV (moderate - severe) acute GVHD[Day + 100 post HLA-matched allogeneic haematopoietic progenitor cell transplantation (HPCT)]

Secondary Outcome Measures

Name	Time	Method
Il-6/IL-6R and Tocilizumab levels post-HPCT assessed by serum assay[2 years post HLA-matched allogeneic HPCT];Effector and regulatory T cell subsets post-HPCT assessed by flow cytometry[2 years post HLA-matched allogeneic HPCT];Incidence of engraftment/infection rate/liver toxicity by medical assessment and blood testing[2 years post HLA-matched allogeneic HPCT]