Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Methods of T Cell Depletion Trial (MoTD) (NCT04888741) is a Phase 2 interventional studying Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by University of Birmingham. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Acute Myeloid Leukemia and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 400 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Thymoglobulin

GVHD prophylaxis

DRUG

Cyclophosphamide

Post transplant cyclophosphamide strategy for GVHD prophylaxis

DRUG

Cyclosporine

immunosuppressant

DRUG

Sirolimus

immunosuppressant

DRUG

Mycophenolate Mofetil

immunosuppressant

Locations (17)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Hospital of Wales
Cardiff, Wales, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Queen Elizabeth Hospital Glasgow
Glasgow, United Kingdom
St Jame's University Hospital
Leeds, United Kingdom
University College London Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
The Christie
Manchester, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
The Royal Marsden Hospital
Sutton, United Kingdom

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04888741), the sponsor (University of Birmingham), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04888741 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04888741?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04888741?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04888741. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04888741. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.