Methods of T Cell Depletion Trial (MoTD) (NCT04888741) | Clinical Trial Compass
RecruitingPhase 2
Methods of T Cell Depletion Trial (MoTD)
United Kingdom400 participantsStarted 2021-02-22
Plain-language summary
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.
Who can participate
Age range16 Years – 70 Years
SexALL
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Inclusion Criteria:
* Availability of suitably matched unrelated donor (9/10 or 10/10)
* Planned to receive one of the following RIC protocols:
* Fludarabine-Melphalan (Fludarabine 120-180mg/m2 IV; melphalan ≤ 150mg/m2 IV)
* BEAM or LEAM (carmustine 300mg/m2 IV or lomustine 200mg/m2 IV with: etoposide 800 mg/m2 IV; cytarabine 1600mg/m2 IV; melphalan 140mg/m2 IV)
* Fludarabine-Busulphan (Fludarabine 120-180mg/m2 IV; Busulphan ≤ 8mg/kg PO or 6.4mg/kg IV)
* Fludarabine- Treosulfan (Fludarabine 150mg/m2 IV; Treosulfan 30g/m2 IV)
* Planned use of PBSCs for transplantation
* Planned allo-SCT for one of the following haematological malignancies:
* AML in CR (patients enrolled onto the COSI trial are not eligible for this study)
* ALL in CR (patients enrolled onto the ALL-RIC trial are not eligible for this study)
* CMML \<10% blasts
* MDS \<10% blasts (patients enrolled onto the COSI trial are not eligible for this study)
* NHL in CR/PR
* HL in CR/PR
* MM in CR/PR
* CLL in CR/PR
* CML in 1st or 2nd chronic phase
* Myelofibrosis
* Age 16-70 years
* Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must agree to use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after transplant
Exclusion Criteria:
* Use of any method of graft manipulation (excluding storage of future DLI)
* Use of alemtuzumab or any method of T cell depletion except those that …