Patient is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:

•

≥ 75 years of age ineligible for intensive chemotherapy per physician’s discretion (with an ECOG performance status 0-2; Appendix C).

•

18-74 years: patient is not eligible for standard chemotherapy because of any of the following co-morbidities:

o

ECOG performance status 2 or 3 (Appendix C).

o

Cardiac history of chronic heart failure requiring treatment; or with an ejection fraction ≤50%; or chronic stable angina.

o

Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or FEV1 ≤ 65%.

o

Creatinine clearance ≥ 30 mL/min to <45 ml/min calculated by the Cockcroft Gault formula.o

Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 x upper limit of normal (ULN).

o

Any other comorbidity that the local physician assesses to be incompatible with intensive chemotherapy. If a patient meets this criterion, sponsor must be informed via HO173@erasmusmc.nl.