Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)
Brief Summary: This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.


Options:
A: Arm Label: Darbepoetin alfa; Type: EXPERIMENTAL; Interventions: Drug: Darbepoetin alfa | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa
B: Arm Label: Darbepoetin alfa - Group A; Type: EXPERIMENTAL; Interventions: Drug: Darbepoetin alfa | Arm Label: Placebo- Group B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa - Group A | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo- Group B
C: 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)
D: Intervention Type: DRUG; Name: epoetin alfa; Assigned to Arm(s): N/A

Answer: C