OncoMatch/Clinical Trials/NCT03104491
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
Is NCT03104491 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Inotuzumab Ozogamicin for acute lymphocytic leukemia.
Treatment: Inotuzumab Ozogamicin — This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects. The Phase II portion of this study is to see what side effects are seen with medication after transplant. Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed/refractory acute lymphocytic leukemia (ALL). Inotuzumab ozogamicin is considered experimental in this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD22 overexpression
Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
Allowed: BCR ABL1 fusion
Philadelphia chromosome positive ALL must have failed at least 1 TKI
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: allogeneic hematopoietic stem cell transplantation — for acute lymphocytic leukemia
Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia
Must have received: chemotherapy
Are relapsed or refractory to at least 1 line of chemotherapy
Must have received: tyrosine kinase inhibitor
Philadelphia chromosome positive ALL must have failed at least 1 TKI
Cannot have received: investigational agent
Participation in any other investigational drug study or had exposure to any other investigational agent, device, or procedure, within 21 days (or 5 half-lives, whichever is greater)
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
Creatinine clearance < 30ml/min
Liver function
Bilirubin > 2X institutional upper limit of normal; AST (SGOT) > 2X institutional upper limit of normal; ALT (SGPT) > 2X institutional upper limit of normal
Patients with inadequate organ function as defined by: Creatinine clearance < 30ml/min; Bilirubin > 2X institutional upper limit of normal; AST (SGOT) > 2X institutional upper limit of normal; ALT (SGPT) > 2X institutional upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Kansas Cancer Center · Westwood, Kansas
- Dana-Farber Cancer Institute · Boston, Massachusetts
- University of Nebraska Medical Center · Omaha, Nebraska
- Memorial Sloan Kettering Cancer Center · New York, New York
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center · Cleveland, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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