Methods of T Cell Depletion Trial (MoTD)

Launched by UNIVERSITY OF BIRMINGHAM · May 10, 2021

Keywords

ClinConnect Summary

The Methods of T Cell Depletion Trial (MoTD) is a research study designed to improve the safety of stem cell transplants for patients with certain blood cancers, like acute myeloid leukemia and multiple myeloma. This trial is comparing two different ways to prevent a condition called graft-versus-host disease (GvHD) after receiving stem cells from a matched unrelated donor. GvHD can happen when the donated stem cells attack the recipient’s body. The study will look at the effectiveness of a treatment called Thymoglobulin compared to other medications used after the transplant.

To participate in this trial, patients must be between 16 and 70 years old and have a suitable donor for their stem cell transplant. They should be planning to receive specific chemotherapy treatments before the transplant and must have one of the qualifying blood cancers. Participants will be closely monitored throughout the trial to see how well the treatments work and ensure their safety. It’s important to note that if someone is pregnant, has certain health issues, or is currently part of another trial, they may not be eligible to join.

Gender

ALL

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.