Table 1 Participant demographics and baseline disease characteristics

From: Axicabtagene ciloleucel in combination with rituximab for refractory large B cell lymphoma: the phase 2, single-arm ZUMA-14 trial

Characteristics

Axi-cel + rituximab (n = 26)

Median age, years (range)

62.5 (38–82)

 ≥65 years, n (%)

12 (46)

Male, n (%)

14 (54)

Race, n (%)

 White

19 (73)

 Asian

3 (12)

 Other

4 (15)

Ethnicity, n (%)

 Not Hispanic or Latino

21 (81)

 Hispanic or Latino

4 (15)

 Not reported

1 (4)

DLBCL type, n (%)

 DLBCL not otherwise specified

16 (62)

 Primary mediastinal LBCL

1 (4)

 DLBCL arising from FL

6 (23)

 High-grade BCL

3 (12)

Cell of origin, n (%)

 GCB

15 (58)

 ABC

5 (19)

 Other

4 (15)

 Not tested

2 (8)

ECOG performance status, n (%)

 0

12 (46)

 1

14 (54)

Disease stage, n (%)

 I

2 (8)

 II

3 (12)

 III

5 (19)

 IV

16 (62)

Disease stage extent, n (%)

 Presence of B symptoms

3 (12)

 Splenic involvement

6 (23)

 Extranodal disease

16 (62)

 Bulky diseasea

2 (8)

Refractory subgroup, n (%)

 Primary refractory

5 (19)

 Refractory to ≥2 lines of therapy

19 (73)

 Refractory after ASCT

2 (8)

aaIPI total score, n (%)

 0

4 (15)

 1

13 (50)

 2

9 (35)

Median LDH, units per liter (range)

246.0 (126.0–1,664.0)

Elevated LDHb, n (%)

10 (38)

Median tumor burden (sum of products of diameters), mm2 (range)

2,225.5 (187.0–14,884.0)

Double/triple hit status, n (%)

 Double hit

6 (23)

 Negative

16 (62)

 Not tested

4 (15)

Alterations/overexpression, n (%)

 BCL2

22 (85)

 BCL6

11 (42)

 c-Myc

9 (35)

Number of prior therapies, n (%)

 1

5 (19)

 2

19 (73)

 ≥3

2 (8)

Prior autologous transplant, n (%)

2 (8)

Prior radiotherapy, n (%)

4 (15)

  1. Safety analysis population (all participants treated with axi-cel). ABC, activated B cell; FL, follicular lymphoma; GCB, germinal center B cell; LDH, lactate dehydrogenase.
  2. aBulky disease was defined as ≥1 lesion ≥ 10 cm in diameter.
  3. bElevated LDH was defined as LDH concentration > upper limit of normal per local laboratory reference range.