phase ii study of post-transplant low-dose inotuzumab ozogamicin to prevent relapse of acute lymphoblastic leukemia

Conditions: Acute Lymphoid Leukemia

Summary: to learn about the safety of post-hsct two dose inotuzumab ozogamicin to participants with high risk b cell acute lymphoblastic leukemia(b-all). also, to learn if giving inotuzumab ozogamicin to post-hsct patients with high-risk b- all can help to reduce relapse and prolong disease free survival and overall survival.

this is a phase ii study of inotuzumab ozogamicin for the treatment of patients who underwent transplantation for all and have a high risk of relapse. participants will receive study treatment two doses until relapse of disease, unacceptable toxicity, or death, whichever occurs first primary objective • to assess the efficacy of inotuzumab ozogamicin as measured by disease free survival (dfs) at one year. secondary objective(s) * to evaluate relapse rate, nonrelapse mortality (nrm), relapse, relapse-related mortality and overall survival (os) at 1 year. * to determine safety profile of inotuzumab ozogamicin after transplant including the incidence of hematological toxicity, secondary graft failure and other adverse event(ae)/severe adverse event(saes)

Eligibility criteria:
inclusion criteria: * diagnosis of cd22-positive acute lymphoblastic leukemia * patients who underwent an allogeneic hematopoietic stem cell transplantation(hsct) from any donor source or auto-hsct for acute lymphocytic leukemia * patients who are after t+60 after transplantation * patients who have/are either: * high risk b-all: (1) high white blood cell(wbc) count when newly diagnosed, (2) poor risk group according to nccn guideline 2021 of acute lymphoblastic * leukemia * relapsed or refractory to at least 1 line of treatment * minimal residual disease(mrd) positive before hsct, including flow cytometry and cytogenetic test * patients who have \> 99% donor chimerism after allogeneic transplantation. * eastern cooperative oncology group(ecog) performance status ≤ 2 * participants must have anc \> 1,000/µl for 3 days and platelet transfusion independence as defined as a platelet count \> 50,000/µl for 7 days. * ≥ 18 years old, including male and female * participants must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients with evidence of disease progression prior to enrollment * persistent prior treatment toxicities grade 2 and above according to nci ctcae version 4.03 (with the exception for alopecia, neuropathy, etc.) * patients with inadequate organ function and can't tolerate the study treatment determined by investigator as defined by: * severe renal deficiency, with creatinine clearance \< 50ml/min * severe hepatic deficiency * bilirubin, aspartate aminotransferase(ast), and/or alt(alt) \> 2x institutional upper limit of normal * severe cardiac or pulmonary deficiency * graft-versus-host disease(gvhd) grade iii or iv (for patients with a prior allogeneic transplant). * active acute or chronic gvhd of the liver (for patients with a prior allogeneic transplant) * history of veno-occlusive disease(vod) * second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) * patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * serologic status reflecting active hepatitis b or c infection. patients that are positive for hepatitis b core antibody, hepatitis b surface antigen (hbsag), or hepatitis c antibody must have a negative polymerase chain reaction (pcr) prior to enrollment. (pcr positive patients will be excluded.) * any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds