Table 2 MUK eight inclusion criteria for switching to ICD treatment
Inclusion criteria for switching to ICD | |
●Randomised and treated in the CD only arm of the MUK eight trial ●Centrally confirmed disease progression by IMWG criteria. This must be confirmed by two consecutive assessments, local laboratory reports and confirmation of this must have been received via email from CTRU. ●ECOG performance status ≤ 2 ●Required laboratory values within 14 days prior to start of ICD treatment: ○ Platelet count ≥ 50 × 109/L. Platelet count of 30–50 is acceptable if bone marrow aspirate shows tumour replacement of > 50%. Platelet transfusions to help patients meet these criteria are not allowed within 72 h prior to the blood sample to confirm eligibility to switch to ICD. ○ Absolute neutrophil count ≥ 1.0 × 109/L. Growth factor support is not permitted within 14 days prior to randomisation ○ Haemoglobin ≥ 90 g/L. Blood support is permitted ○ ALT and / or AST ≤ 3 × upper limit of normal ○ Creatinine clearance ≥ 30 ml/min (using Cockcroft Gault formula) ○ Bilirubin ≤ 1.5 × upper limit of normal ●B2M performed within 14 days prior to the start of ICD treatment ●Female participants should avoid becoming pregnant and male participants should avoid impregnating a female partner. Both non-sterilised and sterilised females and males of reproductive age should use effective methods of contraception during the entire trial treatment (including treatment breaks) and up to 90 days after the last dose of trial treatment. Females of child bearing potential will require a negative pregnancy test to be performed. |