A phase 2 trial of a preventative treatment (cyclophosphamide) for graft-versus-host disease after matched (HLA-identical) allogeneic donor transplant using less intensive chemotherapy
- Conditions
- Graft versus Host DiseaseHaematological malignancyInflammatory and Immune System - Other inflammatory or immune system disordersBlood - Haematological diseasesCancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12613001154796
- Lead Sponsor
- Westmead Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 24
1. Age 15-70 years
2.High risk hematological malignancy suitable for treatment with an allogeneic transplant (acute leukaemia in first remission with poor risk cytogenetics or unfavourable gene mutation profile, or in second or subsequent remission, chronic myeloid leukaemia in first chronic phase not responding to tyrosine kinase inhibitor therapy, poor risk myelodysplastic syndrome, Hodgkin or non-Hodgkin lymphoma failing conventional therapy).
3.Suitable HLA-matched related donor (6/6 match for A, B, DRB1) or unrelated volunteer donor (8 locus match for A, B, C, and DRB1 at allelic level) identified and available.
1. Serious organ dysfunction or uncontrolled infection
2.HIV positive
3.Uncontrolled hepatitis B or C.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective will be to determine the rates of acute GVHD grade III-IV assessed on clinical and laboratory results, according to the consensus criteria published in Przepiorka BMT 1995.<br>[100 days post-transplant]
- Secondary Outcome Measures
Name Time Method