Status:
RECRUITING
Methods of T Cell Depletion Trial (MoTD)
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
IMPACT (funded by NHS Blood & Transplant, Anthony Nolan and Leukaemia UK)
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
Brief 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 cyclophospham...
Detailed Description
This is a prospective, phase II, adaptive, multicentre, randomised clinical trial in patients undergoing reduced intensity conditioned (RIC) unrelated donor allogeneic stem cell transplantation (allo-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04888741
Start Date
February 22 2021
End Date
January 1 2026
Last Update
September 28 2023
Active Locations (15)
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1
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
2
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2GW
3
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
4
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ