Methods of T cell Depletion Trial

Phase 1

• Conditions: Acute Myeloid Leukaemia, Acute lymphoblastic leukaemia, Chronic myelomonocytic leukemia, Myelodysplastic syndromes, Non-Hodgkin lymphoma, Hodgkin lymphoma, Multiple myeloma, Chronic lymphocytic leukaemia, Chronic myeloid leukaemia and Myelofibrosis; MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10009018Term: Chronic myelomonocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10009013Term: Chronic myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts a

• Registration Number: EUCTR2019-002419-24-GB
• Lead Sponsor: The University of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-11
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Availability of suitably matched unrelated donor (9/10 or 10/10)
• Planned to receive one of the following reduced intensity conditioning(RIC)
protocols:
o Fludarabine-melphalan (Fludarabine 120-180mg/m^2; melphalan = 150mg/m^2)
o BEAM or LEAM (carmustine 300mg/m^2 or lomustine 200mg/m^2 with: etoposide 800 mg/m^2; cytarabine 1600mg/m^2; melphalan 140mg/m^2)
o Fludarabine-busulphan (Fludarabine 120-180mg/m^2; Busulphan = 8mg/kg PO or 6.4mg/kg IV)
• Planned use of peripheral blood stem cells (PBSCs) for transplantation
• Planned allo-SCT for one of the following haematological malignancies:
o AML in complete remission (CR)
o ALL in CR
o CMML <10% blasts
o MDS <10% blasts
o NHL in CR/partial remission (PR)
o HL in CR/PR
o MM in CR/PR
o CLL in CR/PR
o CML in 1st or 2nd chronic phase
o 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• Use of any method of graft manipulation (excluding storage of future donor lymphocyte infusion)
• 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 Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection
• Organ dysfunction defined as:
o left ventricular ejection fraction (LVEF) <45%
o Glomerular filtration rate (GFR) <50ml/min
o Bilirubin >50µmol/l
o Aspartate transaminase (AST) or alanine transferase (ALT) >3 x upper limit of normal (ULN)
• Participation in COSI or ALL-RIC trials

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified