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Table 4 miniHCVD-inotuzumab ozogamicin-blinatumomab regimen for acute lymphoblastic leukemia

From: Clinical trial update on bispecific antibodies, antibody-drug conjugates, and antibody-containing regimens for acute lymphoblastic leukemia

Treatment type

Schedule

Drug

Dose

Intensive phase

Cycles 1, 3

Cyclophosphamide

150 mg/m2 every 12 h, days 1–3

Dexamethasone

20 mg/d, days 1–4 and 11–14

Vincristine

2 mg flat dose, days 1 and 8

Cycles 2, 4

Methotrexate

250 mg/m2, day 1

Cytarabine

0.5 g/m2 every 12 hours, days 2 and 3

Cycle 1

Inotuzumab

0.6 mg/m2, day 2 & 0.3 mg/m2, day 8

Cycles 2, 3, 4

Inotuzumab

0.3 mg/m2, days 2 and 8

Cycles 1, 2, 3, 4

Rituximab*

375 mg /m2 day 1 and 8

Consolidation phase

Cycle 5

Blinatumomab

9 μg/day, days 1–4; 28 μg/day days 5–28

Cycles 6, 7, 8

Blinatumomab

28 μg/day days 1–28

Maintenance therapy

Months 1–3, 5–7, 9–11, 13–15

Vincristine

2 mg/d every month

Months 1–3, 5–7, 9–11, 13–15

Prednisone

50 mg/d for 5 days every month

Months 4, 8, 12, 16

Blinatumomab

28 μg/day days 1–28

Months 1–3, 5–7, 9–11, 13–15

6-Mercaptopurine

50 mg PO twice daily

Months 1–3, 5–7, 9–11, 13–15

Methotrexate

10 mg/m2 PO weekly

Central nervous system prophylaxis

Cycles 1, 3

IT MTX-AraC

MTX 12 mg on day 2, AraC 100 mg day 8

Cycles 2, 4

IT AraC-MTX

AraC 100 mg on day 5, MTX 12 mg day 8

Supportive care

Cycles 1–4

Pegfilgrastim

6 mg subcutaneously day 4

Cycles 1–5

Ursodiol

300 mg, 3 times daily

  1. Note: For Intensive phase, inotuzumab ozogamicin (INO) is administered in two split doses on day 2 and day 8. The first dose of INO is 0.6 mg/m2, each subsequent dose is 0.3 mg /m2. In the Consolidation phase, blinatumomab was initiated at 9 μg/day for 4 days and then escalated to 28 μg/day by continuous IV infusion for a total of 4 weeks followed by 2 weeks treatment-free interval, and the cycle is repeated every 6 weeks. *Rituximab was administered in patients with CD20 expression of 20% or higher. It was noted that the schedules of rituximab and CNS prophylaxis have been modified in the latest publications, and variations exist since the trials are still ongoing [116, 117]. For details on correct doses and schedules, those from original publications should be followed
  2. Inotuzumab denotes inotuzumab ozogamicin; IT intrathecal, MTX methotrexate, AraC cytarabine