Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma
Brief Summary: This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6).

The primary objectives of this study are:

* Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens
* Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel
* Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities

Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.


Options:
A: Arm Label: Axicabtagene Ciloleucel Treatment; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Cyclophosphamide, Drug: Fludarabine | Arm Label: Standard of Care Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders. | Intervention Type: BIOLOGICAL; Name: Axicabtagene Ciloleucel; Assigned to Arm(s): Axicabtagene Ciloleucel Treatment | Intervention Type: DRUG; Name: Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.; Assigned to Arm(s): Standard of Care Therapy | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Axicabtagene Ciloleucel Treatment | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): Axicabtagene Ciloleucel Treatment
B: Arm Label: Tisagenlecleucel treatment strategy; Type: EXPERIMENTAL; Interventions: Drug: Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy | Arm Label: Standard of care treatment strategy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT) | Intervention Type: DRUG; Name: Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy; Assigned to Arm(s): Tisagenlecleucel treatment strategy | Intervention Type: DRUG; Name: Platinum-based immunochemotherapy followed in responding patients with high dose chemotherapy and autologous hematopoietic stem cell transplant (HSCT); Assigned to Arm(s): Standard of care treatment strategy
C: Arm Label: Treatment (genetically modified T cell infusion); Type: EXPERIMENTAL; Interventions: Biological: autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells, Procedure: autologous hematopoietic stem cell transplantation, Other: laboratory biomarker analysis | Intervention Type: BIOLOGICAL; Name: autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells; Assigned to Arm(s): Treatment (genetically modified T cell infusion) | Intervention Type: PROCEDURE; Name: autologous hematopoietic stem cell transplantation; Assigned to Arm(s): Treatment (genetically modified T cell infusion) | Intervention Type: OTHER; Name: laboratory biomarker analysis; Assigned to Arm(s): Treatment (genetically modified T cell infusion)
D: Arm Label: Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: Phase 2 (Pivotal Study): Cohort 1; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: Phase 2 (Pivotal Study): Cohort 2; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: Phase 2 (Safety Management Study): Cohort 3; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Levetiracetam, Drug: Tocilizumab | Arm Label: Phase 2 (Safety Management Study): Cohort 4; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Levetiracetam, Drug: Tocilizumab, Drug: Dexamethasone, Drug: High-dose methylprednisolone, Drug: Bendamustine, Drug: Rituximab | Arm Label: Phase 2 (Safety Management Study): Cohort 5; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Levetiracetam, Drug: Rituximab, Drug: Doxorubicin, Drug: Prednisone, Drug: Vincristine, Drug: Ifosfamide, Drug: Carboplatin, Drug: Etoposide, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Cisplatin | Arm Label: Phase 2 (Safety Management Study): Cohort 6; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Levetiracetam, Drug: Tocilizumab, Drug: Dexamethasone, Drug: High-dose methylprednisolone, Drug: Bendamustine, Drug: Rituximab, Drug: Methylprednisolone | Intervention Type: BIOLOGICAL; Name: Axicabtagene Ciloleucel; Assigned to Arm(s): Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy, Phase 2 (Pivotal Study): Cohort 1, Phase 2 (Pivotal Study): Cohort 2, Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy, Phase 2 (Pivotal Study): Cohort 1, Phase 2 (Pivotal Study): Cohort 2, Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy, Phase 2 (Pivotal Study): Cohort 1, Phase 2 (Pivotal Study): Cohort 2, Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Levetiracetam; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Tocilizumab; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: High-dose methylprednisolone; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Bendamustine; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Rituximab; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Doxorubicin; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Prednisone; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Vincristine; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Ifosfamide; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Etoposide; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Oxaliplatin; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Methylprednisolone; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 6

Answer: D