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New treatment option for Acute Myeloid Leukemia
Official title Methods of T Cell Depletion Trial (MoTD)
ClinicalTrials.gov ID: NCT04888741
What this study is testing
What is Thymoglobulin?
Thymoglobulin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as ATG.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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: a mid-size study of how well it works
- Time commitment: about 48 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 70
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cardiff, Wales, United Kingdom
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Glasgow, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Newcastle upon Tyne, United Kingdom
- Nottingham, United Kingdom
- Oxford, United Kingdom
- Plymouth, United Kingdom
- Sheffield, United Kingdom
- Sutton, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cardiff, Wales, United Kingdom; Birmingham, United Kingdom; Bristol, United Kingdom; Cambridge, United Kingdom; Glasgow, United Kingdom; Leeds, United Kingdom and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.