ISRCTN50290131
Active, not recruiting
Phase 2
A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing thymoglobulin vs. calcineurin inhibitor or sirolimus-based post-transplant cyclophosphamide
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- niversity of Birmingham
- Enrollment
- 400
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Current inclusion criteria as of 29/08/2023:
- •1\. Availability of suitably matched unrelated donor (9/10 or 10/10\)
- •2\. Planned to receive one of the following reduced\-intensity conditioning (RIC) protocols:
- •2\.1\. Fludarabine\-melphalan (fludarabine 120\-180 mg/m²; melphalan \=150 mg/m²)
- •2\.2\. BEAM or LEAM (carmustine 300 mg/m² or lomustine 200 mg/m² with: etoposide 800 mg/m²; cytarabine 1600 mg/m²; melphalan 140 mg/m²)
- •2\.3\. Fludarabine\-busulphan (fludarabine 120\-180 mg/m²; busulphan \=8 mg/kg PO or 6\.4 mg/kg IV)
- •2\.4\. Fludarabine\-treosulfan (fludarabine 150 mg/m² IV; treosulfan 30 g/m² IV)
- •3\. Planned use of peripheral blood stem cells (PBSCs) for transplantation
- •4\. Planned allo\-SCT for one of the following haematological malignancies:
- •4\.1\. AML in complete remission (CR)
Exclusion Criteria
- •Current exclusion criteria as of 29/08/2023:
- •1\. Use of any method of graft manipulation (excluding storage of future donor lymphocyte infusion)
- •2\. Use of alemtuzumab or any method of T\-cell depletion except those that are protocol\-defined
- •3\. Known hypersensitivity to study drugs or history of hypersensitivity to rabbits
- •4\. Pregnant or lactating women
- •5\. Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period
- •6\. Life expectancy \<8 weeks
- •7\. Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection
- •8\. Organ dysfunction defined as:
- •8\.1\. Left ventricular ejection fraction (LVEF) \<45%
Investigators
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