RecruitingPhase 2NCT04888741
Methods of T Cell Depletion Trial (MoTD)
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
Sponsor
University of Birmingham
Enrollment
400 participants
Start Date
Feb 22, 2021
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 16 YearsMax Age: 70 Years
Inclusion Criteria20
- 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 Criteria15
- 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 are protocol-defined
- Known hypersensitivity to study drugs or history of hypersensitivity to rabbits
- Pregnant or lactating women
- Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period
- Life expectancy <8 weeks
- Active HBV or HCV infection
- Organ dysfunction defined as:
- LVEF <45%
- GFR <50ml/min
- Bilirubin >50µmol/l
- AST/ALT>3 x ULN
- Participation in COSI or ALL-RIC trials
- Contraindication to treatment with the study drugs (Thymoglobulin, cyclophosphamide, sirolimus, ciclosporin and mycophenolate mofetil) as detailed in each study drug SPC.
- Patient has any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disorder which, in the opinion of the investigator would jeopardise the safety of the patient by taking part in the trial.
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Interventions
DRUGThymoglobulin
GVHD prophylaxis
DRUGCyclophosphamide
Post transplant cyclophosphamide strategy for GVHD prophylaxis
DRUGCyclosporine
immunosuppressant
DRUGSirolimus
immunosuppressant
DRUGMycophenolate Mofetil
immunosuppressant
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04888741
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