Using low-dose Inotuzumab Ozogamicin after transplant to prevent relapse of acute lymphoblastic leukemia
Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia
This study is testing if a low dose of Inotuzumab Ozogamicin can help prevent relapse in people with high-risk B-cell acute lymphoblastic leukemia after they have had a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | Inotuzumab |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06427330 on ClinicalTrials.gov |
What this trial studies
This Phase II study investigates the safety and efficacy of low-dose Inotuzumab Ozogamicin in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) who have undergone hematopoietic stem cell transplantation (HSCT). Participants will receive two doses of the treatment post-transplant to assess its impact on disease-free survival and overall survival. The study aims to evaluate relapse rates, non-relapse mortality, and the safety profile of the drug, monitoring for any adverse events. The primary goal is to determine the effectiveness of the treatment in prolonging disease-free survival at one year.
Who should consider this trial
Good fit: Ideal candidates include adults with CD22-positive B-ALL who have undergone HSCT and are at high risk of relapse.
Not a fit: Patients who do not have CD22-positive B-ALL or those who have not undergone HSCT may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce relapse rates and improve survival outcomes for patients with high-risk B-ALL after transplantation.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific application of low-dose Inotuzumab Ozogamicin post-transplant is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tianjin
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.