Table 1. Study details and completion... | American Society of Hematology

Table 1.

Study details and completion rates for PRO assessments

		Baseline	Treatment period	Disease assessment		Long-term follow-up period
		Baseline	Randomization	D50	D100	D150	M9	M12	M15	M18	M21	M24
Axi-cel	n	165	Patients randomly assigned to treatment with axi-cel received a 3-d conditioning chemotherapy regimen consisting of fludarabine 30 mg/m² per d and cyclophosphamide 500 mg/m² per d followed by 2 rest days. Patients received a single infusion of axi-cel administered IV at a target dose of 2 × 10⁶ anti-CD19 CAR T cells per kg on treatment day 0. Patients will be hospitalized prior to treatment with axi-cel followed by a minimum 7-d observation period.	163	146	110	88	79	67	71	45	32
	%	100		98.8	88.5	66.7	53.3	47.9	40.6	43.0	27.3	19.4
Standard-of- care therapy	n	130	Patients randomly assigned to SOC will receive a second-line combination chemotherapy regimen (R-ICE, R-DHAP, R-ESHAP, or R-GDP) as selected by the treating investigator. Patients will receive 2 cycles of chemotherapy administered every 2 to 3 weeks. Patients responding to second-line combination chemotherapy after 2 cycles should proceed with 1 additional chemotherapy cycle or directly to HDCT and ASCT. Patients who do not respond to second-line chemotherapy can receive additional treatment off protocol.	125	62	56	40	33	26	23	20	12
	%	99.2		95.4	47.3	42.7	30.5	25.2	19.8	17.6	15.3	9.2

		Baseline	Treatment period	Disease assessment		Long-term follow-up period
		Baseline	Randomization	D50	D100	D150	M9	M12	M15	M18	M21	M24
Axi-cel	n	165	Patients randomly assigned to treatment with axi-cel received a 3-d conditioning chemotherapy regimen consisting of fludarabine 30 mg/m² per d and cyclophosphamide 500 mg/m² per d followed by 2 rest days. Patients received a single infusion of axi-cel administered IV at a target dose of 2 × 10⁶ anti-CD19 CAR T cells per kg on treatment day 0. Patients will be hospitalized prior to treatment with axi-cel followed by a minimum 7-d observation period.	163	146	110	88	79	67	71	45	32
	%	100		98.8	88.5	66.7	53.3	47.9	40.6	43.0	27.3	19.4
Standard-of- care therapy	n	130	Patients randomly assigned to SOC will receive a second-line combination chemotherapy regimen (R-ICE, R-DHAP, R-ESHAP, or R-GDP) as selected by the treating investigator. Patients will receive 2 cycles of chemotherapy administered every 2 to 3 weeks. Patients responding to second-line combination chemotherapy after 2 cycles should proceed with 1 additional chemotherapy cycle or directly to HDCT and ASCT. Patients who do not respond to second-line chemotherapy can receive additional treatment off protocol.	125	62	56	40	33	26	23	20	12
	%	99.2		95.4	47.3	42.7	30.5	25.2	19.8	17.6	15.3	9.2

Completion rates within the table reflect completion of the EORTC QLQ-C30 global health status/QoL domain. Differences in sample size at specified timepoints were as follows for the hypothesis-driven scales: physical functioning had 164 patients in the axi-cel arm at baseline and 109 at day 150, and within the SOC therapy arm, 131 patients completed at baseline, 126 at day 50, and 64 at day 100; EQ-5D VAS had 145 patients in the axi-cel arm complete at day 100, 80 at month 12, 70 at month 18, and 32 at month 24, and for the SOC therapy arm, 130 completed at baseline, 126 at day 50, and 65 at day 100. PRO instruments were administered until 24 mo or an EFS event (disease progression, all-cause death, or new lymphoma therapy).

R-DHAP, rituximab, dexamethasone, high-dose cytarabine; R-ESHAP, rituximab, etoposide, methylprednisolone, cytarabine, cisplatin; R-GDP, rituximab, gemcitabine, dexamethasone, cisplatin/carboplatin; R-ICE, rituximab, ifosfamide, carboplatin, etoposide.

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