Bone Marrow Biopsy Sample Clauses

Bone Marrow Biopsy. A bone marrow aspirate/biopsy will be performed at screening, if not previously performed within 4 weeks of signing consent, to assess bone marrow involvement. The bone marrow aspirate and biopsy will be assessed and confirmed for the presence of MCL. Subjects with a positive bone marrow at screening or those who do not have a baseline bone marrow biopsy available, must undergo another bone marrow aspirate and biopsy upon first determination of a complete response via PET. Subjects with a negative bone marrow aspirate/biopsy (ie, no MCL) at screening, and patients with a partial metabolic response, stable disease (SD) or progressive disease (PD) at any disease response assessment time point do not require a follow-up bone marrow aspirate and biopsy (Figure 3)