Leland Metheny, Ronald M Sobecks, Christina Cho, Pingfu Fu, Seunghee Margevicius, Jiasheng Wang, Lisa Ciarrone, Shelby Kopp, Robin Convents, Navneet S Majhail, Paolo F. Caimi, Folashade Otegbeye, Brenda W Cooper, Molly M Gallogly, Ehsan Malek, Benjamin K Tomlinson, Aaron T. Gerds, Betty K. Hamilton, Sergio A. Giralt, Miguel-Angel Perales, Marcos de Lima

A multicenter study of posttransplant low-dose inotuzumab ozogamicin to prevent relapse of acute lymphoblastic leukemia

  • Hematology

The curative potential of allogeneic hematopoietic transplant (alloHCT) in patients with acute lymphoblastic leukemia (ALL) is hampered by relapse. Inotuzumab ozogamicin (INO) is an anti-CD22 monoclonal antibody bound to calicheamicin which has significant activity against ALL. We hypothesized that low-dose INO would be safe and feasible post alloHCT. Therefore we conducted a phase I study to determine the dose and safety in this setting. Patients were eligible if they were aged 16-75, had undergone alloHCT for CD22+ALL, were in complete remission (CR) after alloHCT, had high-risk of recurrence, were between day 40 and 100 post-alloHCT with adequate graft function, and did not have a history of hepatic veno-occlusive disease (VOD). The objectives of this trial were to define INO maximum tolerated dose (MTD), to determine the post alloHCT INO safety, and to measure one-year progression-free-survival (PFS). The trial design followed a 3+3 model. The treatment consisted of INO given on day 1 of 28-day cycles. Dose levels were 0.3mg/m2, 0.4mg/m2, 0.5mg/m2, and 0.6mg/m2. Median age was 44 years (range, 17-66; n=18). Disease status at transplant was first CR (n=14) or second CR or beyond (n=4). Preparative regimen was of reduced intensity in 72% of the transplants. Most common toxicity was thrombocytopenia. There were no instances of VOD; the MTD was 0.6mg/m2. One-year non-relapse mortality was 5.6%. With a median follow up of 18.1 months (8.6-59 months) one-year post-alloHCT PFS and OS is 89% and 94%, respectively. ClinicalTrials.gov Identifier: NCT03104491.

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