Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia

Trial Title: Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia

NCT ID: NCT06427330

Condition: Acute Lymphoid Leukemia

Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Inotuzumab Ozogamicin

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Inotuzumab ozogamicin
Description: 1. st dose is given after D+60：inotuzumab 0.3mg/m2 2. nd dose is given after 1 month：inotuzumab 0.6mg/m2
Arm group label: Inotuzumab ozogamicin

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.

Detailed description: 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)

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Address:
City: Tianjin
Country: China

Status: Recruiting

Contact:
Last name: Erlie Jiang

Phone: +86-15122538106
Email: jiangerlie@ihcmas.ac.cn

Start date: July 2, 2024

Completion date: June 30, 2026

Lead sponsor:
Agency: Institute of Hematology & Blood Diseases Hospital, China
Agency class: Other

Source: Institute of Hematology & Blood Diseases Hospital, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06427330