OncoMatch/Clinical Trials/NCT06427330
Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia
Is NCT06427330 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Inotuzumab ozogamicin for acute lymphoid leukemia.
Treatment: Inotuzumab ozogamicin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD22 overexpression (positive)
Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hematopoietic stem cell transplant — allogeneic or autologous
Patients who underwent an allogeneic hematopoietic stem cell transplantation(HSCT) from any donor source or auto-HSCT for acute lymphocytic leukemia
Lab requirements
Blood counts
ANC > 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count > 50,000/µL for 7 days
Kidney function
Severe renal deficiency, with creatinine clearance < 50ml/min
Liver function
Severe hepatic deficiency; Bilirubin, AST, and/or ALT > 2X institutional upper limit of normal
Cardiac function
Severe cardiac deficiency
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. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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