Table 1 Patients’ characteristics

From: Outcome of aggressive B-cell lymphoma with TP53 alterations administered with CAR T-cell cocktail alone or in combination with ASCT

Characteristics

Values

P

Group A, Trial A (W/O TP53 Alterations)

Group B, Trial A (With TP53 Alterations)

Group C, Trial B (With TP53 Alterations)

Group D, Trial B (W/O TP53 Alterations)

Patients number

34

32

28

29

 

Age, median (range)

50 (17–69)

47 (29–63)

40 (23–61)

39 (24–61)

0.070

Gender (M/F)

21/13

22/10

18/10

16/13

0.742

ECOG PS

    

0.386

0–1

20 (58.8%)

22 (68.8%)

16 (57.1%)

22 (75.9%)

 

2

14 (41.2%)

10 (31.3%)

12 (42.8%)

7 (24.1%)

 

Pathologic subtype

    

0.237

DLBCL, NOS

20 (58.8%)

26 (81.2%)

18 (64.3%)

22 (75.9%)

 

DLBCL-tFL

6 (17.6%)

3 (9.4%)

4 (14.3%)

4 (13.8%)

 

HGBL DH/TH

5 (14.7%)

0 (0.0%)

2 (7.1%)

3 (10.3%)

 

HGBL, NOS

2 (5.8%)

1 (3.1%)

0 (0.0%)

0 (0.0%)

 

Burkitt lymphoma

1 (2.9%)

1 (3.1%)

2 (7.1%)

0 (0.0%)

 

MCL

0 (0.0%)

1 (3.1%)

0 (0.0%)

0 (0.0%)

 

Othersa

0 (0.0%)

0 (0.0%)

2 (7.1%)

0 (0.0%)

 

Tumor mass

    

0.160

≥5 cm

13 (38.2%)

16 (50.0%)

7(25.0%)

8 (27.6%)

 

Disease status

    

0.409

Primary refractory

6 (17.6%)

12 (37.5%)

8 (28.6%)

12 (41.4%)

 

First relapse

16 (47.0%)

6 (18.8%)

10 (35.7%)

10 (14.5%)

 

Second relapse

8 (23.5%)

9 (28.1%)

7 (25.0%)

4 (13.8%)

 

≥ 3rd relapse

4 (11.8%)

5 (15.6%)

3 (10.7%)

3 (10.3%)

 

No. of treatment lines

    

0.174

2

10 (29.4%)

3 (9.4%)

8 (28.6%)

4 (13.8%)

 

3

13 (38.2%)

10 (31.3%)

11 (39.3%)

11 (37.9%)

 

≥4

11 (32.4%)

19 (59.4%)

9 (32.1%)

14 (48.3%)

 

Previous ASCT

6 (17.6%)

6 (18.8%)

1 (3.6%)

1 (3.4%)

0.088

Previous CART

0 (0%)

0 (0%)

3 (10.7%)

1 (3.4%)

0.066

Bridging treatmentb

8 (23.5%)

9 (28.1%)

3 (10.7%)

3 (10.3%)

0.180

Baseline LDH ratio

    

0.380

<1Ă—ULN

14 (41.2%)

11 (34.4%)

9 (32.1%)

10 (14.5%)

 

1–3×ULN

16 (47.0%)

18 (56.2%)

11 (39.3%)

16 (55.2%)

 

≥4×ULN

4 (11.8%)

3 (9.4%)

8 (28.6%)

3 (10.3%)

 

Disease stagec

    

0.647

I or II

6 (17.6%)

4 (12.5%)

4 (14.3%)

7 (24.1%)

 

III or IV

28 (82.4%)

28 (87.5%)

24 (85.7%)

22 (75.9%)

 

Response at enrollment

    

0.796

PR

27 (79.4%)

26 (81.2%)

23 (82.1%)

21 (72.4%)

 

PD/SD

7 (20.6%)

6 (18.8%)

5 (17.9%)

8 (27.6%)

 

IPI score

    

0.800

0–2

15 (44.1%)

13 (40.6%)

10 (35.7%)

14 (48.3%)

 

3–4

19 (55.9%)

19 (59.4%)

18 (64.3%)

15 (51.7%)

 

Cell of origin (n = 113)

    

0.520

GCB

13 (38.2%)

14 (43.8%)

8 (28.6%)

9 (31.0%)

 

non-GCB

18 (52.9%)

15 (46.9%)

16 (57.1%)

20 (69.0%)

 

Dosage of CAR T cells (Ă—106/kg)

CAR19, median (range)

4.0 (1.4–7.7)

4.9 (1.9–8.9)

4.0 (2.1–12.6)

4.0 (1.0–10.0)

0.164

CAR22, median (range)

5.9 (2.1–10.0)

6.0 (1.0–11.4)

4.0 (2.1–6.3)

4.0 (0.8–10.0)

0.074

  1. aOthers, including 1 with B-cell lymphoma, unclassified with properties between DLBCL and classical Hodgkin lymphoma, and 1 with B-cell lymphoblastic lymphoma;
  2. bDisease stage based on the modified Ann Arbor staging system. W/O without, ECOG PS Eastern Cooperative Oncology Group (ECOG) performance status, DLBCL NOS diffuse large B-cell lymphoma, not otherwise specified, DLBCL-tFL diffuse large B-cell lymphoma transformed from follicular lymphoma (FL), HGBL DH/TH high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, HGBL NOS HGBL, not otherwise specified, MCL mantle cell lymphoma, ASCT autologous stem cell transplantation;
  3. cBridging treatment, including radiotherapy, ibrutinib, glucocorticoid, sequential ifosfamide and etoposide, and rituximab et al between hematopoietic stem cell & T cell collection and lymphodepletion or myeloablative chemotherapy before infusion of CART, LDH lactate dehydrogenase, ULN upper limit of normal, PR partial response, SD stable disease, PD progressive disease, IPI international prognostic index, GCB germinal center B-cell like.
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