Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)
Brief Summary: The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.


Options:
A: Arm Label: Ofatumumab; Type: EXPERIMENTAL; Interventions: Drug: Ofatumumab | Arm Label: Physicians' Choice; Type: ACTIVE_COMPARATOR; Interventions: Drug: Physicians' Choice | Intervention Type: DRUG; Name: Ofatumumab; Assigned to Arm(s): Ofatumumab | Intervention Type: DRUG; Name: Physicians' Choice; Assigned to Arm(s): Physicians' Choice
B: Arm Label: Rituximab + PCI-32765; Type: EXPERIMENTAL; Interventions: Drug: Rituximab, Drug: PCI-32765 | Intervention Type: DRUG; Name: Rituximab; Assigned to Arm(s): Rituximab + PCI-32765 | Intervention Type: DRUG; Name: PCI-32765; Assigned to Arm(s): Rituximab + PCI-32765
C: Arm Label: Ofatumumab (Arm A); Type: ACTIVE_COMPARATOR; Interventions: Drug: ofatumumab | Arm Label: ibrutinib (Arm B); Type: EXPERIMENTAL; Interventions: Drug: ibrutinib | Intervention Type: DRUG; Name: ofatumumab; Assigned to Arm(s): Ofatumumab (Arm A) | Intervention Type: DRUG; Name: ibrutinib; Assigned to Arm(s): ibrutinib (Arm B)
D: Arm Label: Arm A (ibrutinib, rituximab); Type: EXPERIMENTAL; Interventions: Drug: Ibrutinib, Other: Laboratory Biomarker Analysis, Other: Pharmacogenomic Study, Other: Quality-of-Life Assessment, Biological: Rituximab | Arm Label: Arm B (rituximab, fludarabine phosphate, cyclophosphamide); Type: ACTIVE_COMPARATOR; Interventions: Drug: Cyclophosphamide, Drug: Fludarabine Phosphate, Other: Laboratory Biomarker Analysis, Other: Pharmacogenomic Study, Other: Quality-of-Life Assessment, Biological: Rituximab | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Arm B (rituximab, fludarabine phosphate, cyclophosphamide) | Intervention Type: DRUG; Name: Fludarabine Phosphate; Assigned to Arm(s): Arm B (rituximab, fludarabine phosphate, cyclophosphamide) | Intervention Type: DRUG; Name: Ibrutinib; Assigned to Arm(s): Arm A (ibrutinib, rituximab) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm A (ibrutinib, rituximab), Arm B (rituximab, fludarabine phosphate, cyclophosphamide) | Intervention Type: OTHER; Name: Pharmacogenomic Study; Assigned to Arm(s): Arm A (ibrutinib, rituximab), Arm B (rituximab, fludarabine phosphate, cyclophosphamide) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm A (ibrutinib, rituximab), Arm B (rituximab, fludarabine phosphate, cyclophosphamide) | Intervention Type: BIOLOGICAL; Name: Rituximab; Assigned to Arm(s): Arm A (ibrutinib, rituximab), Arm B (rituximab, fludarabine phosphate, cyclophosphamide)

Answer: A