Clinical trial · Interventional
Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin 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
NCT06427330CI-TRIAL-00079246unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inotuzumab ozogamicin | Drug | Inotuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Inotuzumab ozogamicin
- interventionNames
- Drug: Inotuzumab ozogamicin
Primary outcomes (1)
- measure
- DFS
- timeFrame
- at one year after HSCT
- description
- Efficacy as measured by DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of HSCT to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)".
Secondary outcomes (6)
- measure
- Overall survival
- timeFrame
- at one year after HSCT
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDavis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067. PMID 41671463