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Table 3 Selected ongoing clinical trials of inotuzumab ozogamicin for patients with newly diagnosed B-cell ALL

From: Inotuzumab ozogamicin for the treatment of adult acute lymphoblastic leukemia: past progress, current research and future directions

Trial

Age (years)

ALL subtypes

Primary endpoint

Data presented or published

Trial identifier

INO induction followed by low-intensity chemotherapy (INITIAL-1)

56–74

Ph-negative

Event-free survival

Yes [36]

NCT03460522

INO + dasatinib + dexamethasone

18+

Ph-positive

Complete remission with MMR

No

NCT04747912

INO + blinatumomab + hyper-CVAD

14+

Ph-negative

Relapse-free survival

Yes [40]

NCT02877303

INO + blinatumomab + mini-hyper-CVD

60+

Ph-negative or Ph-positive

Progression-free survival

Yes [33]

NCT01371630

INO + mini-hyper-CVD versus dose-adjusted hyper-CVAD (Alliance A042001)

50+

Ph-negative

Event-free survival

No

NCT05303792

INO induction followed by blinatumomab (Alliance 041703)

60+

Ph-negative

Event-free survival

Yes [35]

NCT03739814

INO + low-intensity chemotherapy (EWALL-INO)

55+

Ph-negative

Overall survival

Yes [37]

NCT03249870

  1. Abbreviations: INO, inotuzumab ozogamicin; Ph, Philadelphia chromosome; MMR, major molecular response