NCT04888741 Methods of T Cell Depletion Trial (MoTD)
| NCT ID | NCT04888741 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Birmingham |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2021-02-22 |
| Primary Completion | 2027-08-23 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 400 participants in total. It began in 2021-02-22 with a primary completion date of 2027-08-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 cyclophosphamide.
Eligibility Criteria
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 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.
Contact & Investigator
Ronjon Professor Chakraverty
STUDY DIRECTOR
Oxford Cancer & Haematology Centre, The Churchill Hospital, Old Road - Headington, Oxford, OX3 7LE Email: ronjon.chakraverty@ndcls.ox.ac.uk
Frequently Asked Questions
Who can join the NCT04888741 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 70 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04888741 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04888741 currently recruiting?
Yes, NCT04888741 is actively recruiting participants. Contact the research team at MoTD@trials.bham.ac.uk for enrollment information.
Where is the NCT04888741 trial being conducted?
This trial is being conducted at Cardiff, United Kingdom, Birmingham, United Kingdom, Bristol, United Kingdom, Cambridge, United Kingdom and 11 additional locations.
Who is sponsoring the NCT04888741 clinical trial?
NCT04888741 is sponsored by University of Birmingham. The principal investigator is Ronjon Professor Chakraverty at Oxford Cancer & Haematology Centre, The Churchill Hospital, Old Road - Headington, Oxford, OX3 7LE Email: ronjon.chakraverty@ndcls.ox.ac.uk. The trial plans to enroll 400 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.