2  Ph negative B-ALL

2.1 Mini-hyper-CVD plus Inotuzumab ozagamicin with Blinatumomab

Recently published literature showed (Jabbour et al. 2023)

Chemotherapy, Mini-Hyper-CVD portion (cycles 1, 3, 5, 7; “Part A”)

• Cyclophosphamide (Cytoxan) 150 mg/m² IV every 12 hours on days 1 to 3 (total dose per cycle: 900 mg/m²)

• Vincristine (Oncovin) 2 mg IV once per day on days 1 & 8

Glucocorticoid therapy, Mini-Hyper-CVD portion (cycles 1, 3, 5, 7; “Part A”)

• Dexamethasone (Decadron) 20 mg IV or PO once per day on days 1 to 4, 11 to 14

Antibody-drug conjugate therapy, Mini-Hyper-CVD portion (“Part A”)

• Inotuzumab ozogamicin (Besponsa) as follows:

  • Cycles 1 & 3: 1.3 to 1.8 mg/m² IV once on day 3

  • Cycles 5 & 7: 1 to 1.3 mg/m² IV once on day 3

Chemotherapy, MA portion (cycles 2, 4, 6, 8; “Part B”)

• Methotrexate (MTX) 250 mg/m² IV once on day 1

• Cytarabine (Ara-C) 500 mg/m² IV every 12 hours on days 2 & 3 (total dose per cycle: 2000 mg/m²)

Antibody-drug conjugate therapy, MA portion (“Part B”)

• Inotuzumab ozogamicin (Besponsa) as follows:

  • Cycles 2 & 4: 1.3 to 1.8 mg/m² IV once on day 3

  • Cycles 6 & 8: 1 to 1.3 mg/m² IV once on day 3

28-day cycle for 8 cycles

---

Jabbour, Elias, Nicholas J Short, Jayastu Senapati, et al. 2023. “Mini-Hyper-CVD Plus Inotuzumab Ozogamicin, with or Without Blinatumomab, in the Subgroup of Older Patients with Newly Diagnosed Philadelphia Chromosome-Negative b-Cell Acute Lymphocytic Leukaemia: Long-Term Results of an Open-Label Phase 2 Trial.” The Lancet Haematology 10 (6): e433–44. https://doi.org/10.1016/s2352-3026(23)00073-x.