A Phase II Study of the Impact of Two Different Schedules of Thymoglobulin on the Incidence of Extensive Chronic Graft Verus Host Disease (GVHD) in Patients Undergoing Unrelated Donor or Mismatched Related Donor Stem Cell Transplantatio

Phase 2

Recruiting

• Conditions: Chronic Graft versus Host Disease in Haematology Malignancy Patients receiving donor stem cell transplantation; Cancer - Other cancer types

• Registration Number: ACTRN12609000173291
• Lead Sponsor: The Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.age > 18 years
2.undergoing an unrelated or mismatched related peripheral blood stem cell (PBSC) allograft
3.no contra-indication to receiving Thymoglobulin
4.life expectancy >3 months
5.absence of active invasive fungal infection at the time of transplant
6.myeloablative conditioning (including cy/TBI, VP16/TBI fludarabine-melphalan >120mg/m2, fludarabine-busulphan at a dose at least equivalent to 3.2mg/kg intravenous (IV) per day for 4 days and by-cy. IV busulphan will be used, given as a single daily dose of 3.2mg/kg at a rate of 80mg/hr. Monitoring, if available, will be done to conform with local guidelines

Exclusion Criteria

1.active invasive fungal infection at the time of transplant
2.contra-indication to receiving Thymoglobulin
3.Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the incidence of extensive chronic GVHD at one and two years in patients receiving Thymoglobulin prophylaxis, with historical controls of patients who did not receive Thymoglobulin (or any form of T cell depletion), but who are otherwise comparable for other transplant characteristics. For this purpose patients receiving the two different Thymoglobulin schedules will be analysed together. Grading of acute GVHD will be done according to Glucksberg/Seattle criteria. The scoring system from Filipovich (BBMT 2005) will be used to grade the severity of chronic GVHD.[1 and 2 years after study opening];To evaluate the relationship between rabbit IgG levels at the time of stem cell infusion and GVHD outcome. This will be using an assay on a blood sample.[1 and 2 years after study opening]