Clinical trial · Interventional
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
NCT04888741CI-TRIAL-00110380MoTDrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cyclosporine | Drug | — | UNRESOLVED |
| Mycophenolate Mofetil | Drug | — | UNRESOLVED |
| Sirolimus | Drug | Sirolimus | ALIAS |
| Thymoglobulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Control Arm Thymoglobulin + Cyclosporine + MMF
- description
- Thymoglobulin is given as an intravenous infusion of 2.5 mg/kg/day over 2 days (days -2 and -1; total dose 5 mg/kg) via a central line through a 0.2 micron inline filter. Each dose will be infused over 6-8 hours. No test dose will be given. 30 minutes before Thymoglobulin, the patient should receive methylprednisolone 1mg/kg intravenously, 1g paracetamol PO and 10mg chlorphenamine IV. Patients should be monitored carefully and receive appropriate therapy for any infusion-related or anaphylactic reactions as per local policy. Patients will receive IV/PO cyclosporine according to local policy to begin on day -1 maintaining a trough level of 100-200 µg/L until day 90 before a subsequent taper in the absence of any active GvHD. MMF will be given IV/PO according to local policy at a dose of 1g TDS to begin on day -1 and discontinued on day 35 without taper if there is no evidence of active GvHD. In adults weighing \<55kg, MMF should be given at a lower dose of 0.75g IV/PO TDS.
- interventionNames
- Drug: Thymoglobulin
- Drug: Cyclosporine
- Drug: Mycophenolate Mofetil
- type
- EXPERIMENTAL
- label
- Experimental arm (PTCy + Cyclosporine + MMF)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.