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Comparing T Cell Depletion Methods for Blood Cancer Treatment

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

Phase 2 Interventional University of Birmingham · NCT04888741

This study is testing different ways to prevent complications after a stem cell transplant for blood cancer to see which method helps patients stay healthy and cancer-free longer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment400 (estimated)
Ages16 Years to 70 Years
SexAll
SponsorUniversity of Birmingham Academic / other
Drugs / interventionsalemtuzumab, cyclophosphamide, Fludarabine, rituximab
Locations17 sites (Cardiff, Wales and 16 other locations)
Trial IDNCT04888741 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with specific hematological malignancies who are planned to receive unrelated donor allogeneic stem cell transplantation.

Not a fit: Patients who do not have a suitably matched unrelated donor or those with certain disease statuses may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could improve survival rates and reduce complications for patients undergoing stem cell transplantation for blood cancers.

How similar studies have performed: Other studies have shown promise with similar GvHD prophylaxis approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Cardiff, Wales and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaAcute Lymphoblastic LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic SyndromesNon Hodgkin LymphomaHodgkin LymphomaMultiple MyelomaChronic Myelogenous Leukemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.