Table 1 Baseline characteristics and outcomes (n = 49).

From: Real world outcomes with the use of Inotuzumab Ozogamicin in relapsed/refractory B cell acute lymphoblastic leukemia

Characteristic

Number (%) or Median (Range)

Age (in years)

24 (6–68)

Male sex

39 (79.5)

Disease type

 1. Primary refractory disease

9 (18.3)

 2. Very early/early relapse

24 (48.9)

 3. Late relapse

9 (18.3)

 4. Post-transplant relapse

7 (14.2) (1 CR1, 5 CR2 and 1 CR3 transplant)

Cytogenetics

Normal

24 (48.9)

Abnormal

22 (44.9)

 

 1. Ph+ve (n = 6)

 

 2. High Risk Cytogenetics (n = 8) (Hypodiploidy (n = 2), Complex karyotype (n = 5), KMT2Ar (n = 1))

 

 3. Others (n = 8)

Not Available

3 (6.2)

Extent of disease prior to InO

 1. Peripheral blood WBC count

4600 per cu.mm (600–12200)

 2. Proportion of peripheral blasts on morphology

0 (0–79)

 3. Proportion of marrow blasts on morphology

44 (8–92)

 4. CNS disease

6 (12.2)

 5. Testicular disease

1 (2)

Pattern of InO use

 1. Single agent InO

43 (87.7)

 2. Single agent InO with triple intrathecal

2 (4)

 3. Along with chemotherapy/other agents

4 (2–Mini-HyperCVAD, 2–Dasatinib) (8.1)

Median number of doses of InO used

3(1–12)

Line of salvage of InO

 1. First line

4 (8.1)

 2. Second line

19 (38.7)

 3. Third or later

26 (53)

Response to salvage InO

 1. Not assessed

5 (10.2)

 2. Remission

28 (57.1) (of which 20 were MRD negative) (Median doses of InO – 4(2–12))

 3. No response

16 (32.6) (Median doses of InO – 3 (2–9))

Subsequent treatment following response (N = 28)

 Hematopoietic stem cell transplantation

18 (64.3)

 CAR T

1 (3.6)

Causes of Death

 1. Death due to progressive disease

13 (26.5)

 2. Death while in remission

11 (22.4) (Sepsis (8), SOS (1), and cerebrovascular accident (2))

Median follow-up of the entire cohort from initiation of InO

6 (1–41) months

Median follow-up of the surviving patients

10.5 (2–24) months

  1. InO inotuzumab ozogamicin, CR complete remission, MRD measurable residual disease, CNS central nervous system, DLI donor lymphocyte infusion, CAR-T chimeric antigen receptor T cell therapy, SOS hepatic sinusoidal obstruction syndrome