Comparing T Cell Depletion Methods for Blood Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates different graft-versus-host disease (GvHD) prophylaxis regimens in patients undergoing unrelated donor allogeneic stem cell transplantation. It compares the effectiveness of post-transplant cyclophosphamide combined with either a calcineurin inhibitor or sirolimus against the standard T-cell depletion method using Thymoglobulin. The study aims to determine which method provides better GvHD-free, relapse-free survival and assesses various secondary outcomes related to patient health post-transplant. Patients will be randomly assigned to one of the three treatment arms based on specific eligibility criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital of Wales
  Cardiff, Wales, United Kingdom Recruiting
• Queen Elizabeth Hospital
  Birmingham, United Kingdom Recruiting
• Bristol Haematology and Oncology Centre
  Bristol, United Kingdom Recruiting
• Addenbrookes Hospital
  Cambridge, United Kingdom Recruiting
• Queen Elizabeth Hospital Glasgow
  Glasgow, United Kingdom Recruiting
• St Jame's University Hospital
  Leeds, United Kingdom Recruiting

Study contacts

• Study coordinator: MoTD Trial
• Email: MoTD@trials.bham.ac.uk
• Phone: 0121 371 7859

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Reduced-intensity conditioning to lower treatment-related mortality in stem cell transplant patients

  This study is testing a new way to prepare patients for a stem cell transplant to see if it can lower the risk of serious treatment-related complications.

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• Using post-transplant cyclophosphamide and ATG for blood cancer transplants

  This study is testing whether using post-transplant cyclophosphamide and ATG can help prevent graft-versus-host disease in patients with blood cancers who are getting stem cell transplants.

  Recruiting Phase 1/2 Instituto Nacional de Cancer, Brazil · Rio de Janeiro, Rio de Janeiro · NCT06299462

• CMV Triplex vaccine to boost immunity and prevent CMV after haploidentical stem cell transplant

  This trial tests whether giving a CMV-MVA Triplex vaccine to donors and/or recipients, with or without the antiviral letermovir, can boost CMV immunity and prevent CMV viremia in people having haploidentical stem cell transplants.

  Recruiting at 3 sites Phase 1 City of Hope Medical Center · Duarte, California and 2 other locations · NCT07020533

• Vaccination to prevent CMV infection in stem cell transplant patients

  This study is testing a new vaccine to see if it can help prevent CMV infections in patients receiving stem cell transplants from related donors.

  Recruiting at 3 sites Phase 2 City of Hope Medical Center · Duarte, California and 2 other locations · NCT06059391

• Hematopoietic stem cell transplant for blood cancers

  This study is testing two different ways of doing stem cell transplants for people with blood cancers to see which method works better and is safer.

  Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT03314974

• Cord blood transplant for children and young adults with blood cancers.

  This study will test whether a cord blood transplant given as a first or second transplant can help children and young adults with leukemia, myelodysplasia, or lymphoma who lack a matched donor.

  Recruiting Phase 2 Memorial Sloan Kettering Cancer Center · New York, New York · NCT07566377

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.