A RANDOMISED STUDY TO COMPARE THE REDUCED INTENSIVE REGIMEN CONTAINING ALEMTUZUMAB VERSUS ATG IN ALLOGENIC TRAPIANTS FROM MUD

INTERVENTION: Trade Name: ALKERAN*1FL 50MG/10ML+FL 10ML Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Melphalan CAS Number: 148‐82‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Trade Name: FLUDARA*EV 5FL 50MG Pharmaceutical Form: Solution for injection INN or Proposed INN: Fludarabine CAS Number: 75607‐67‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: MABCAMPTH Pharmaceutical Form: Solution for infusion INN or Proposed INN: Alemtuzumab CAS Number: 75607‐67‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Trade Name: SANDIMMUN NEORAL*50ML 100MG/ML Pharmaceutical Form: Oral solution INN or Proposed INN: Ciclosporin CAS Number: 59865‐59‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: THIOPLEX*INIET 1F 15MG Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Thiotepa CAS Number: 52‐24‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ Trade Name: ENDOXAN BAXTER*EV 1FL 1G Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Cyclophosphamide CAS Number: 6055‐19‐2 Concentration unit: g gram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Antithymocyte immunoglobulin rabbit CAS Number: 6055‐19‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Trade Name: SANDIMMUN*INFUS 10F 5ML 50MG/M Pharmaceutical Form: Solution for infusion INN or Proposed INN: Ciclosporin CAS Number: 59865‐59‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: METHOTREXATE*INIET FL 50MG 2ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Methotrexate CAS Number: 59‐05‐2 Concentration uni CONDITION: CONDITIONING WITH REDUCED INTENSIVE REGIMEN IN ALLOGENI TRANSPLANT FROM MUD PRIMARY OUTCOME: Main Objective: Primary end point(s): Secondary Objective: INCLUSION CRITERIA: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range