OncoMatch/Clinical Trials/NCT03739814
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
Is NCT03739814 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Blinatumomab and Inotuzumab Ozogamicin for b acute lymphoblastic leukemia, philadelphia chromosome negative.
Treatment: Blinatumomab · Inotuzumab Ozogamicin · Ponatinib — This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD22 overexpression (≥ 20% of lymphoblasts)
CD22-positive disease defined as CD22 expression by ≥ 20% of lymphoblasts by local hematopathology evaluation.
Excluded: BCR fusion
Philadelphia chromosome/BCR-ABL1-negative or Philadelphia chromosome/BCR-ABL1-positive B-cell ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR).
Excluded: ABL1 fusion
Philadelphia chromosome/BCR-ABL1-negative or Philadelphia chromosome/BCR-ABL1-positive B-cell ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR).
Disease stage
Required: Stage NEWLY DIAGNOSED, REFRACTORY
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Kidney function
Creatinine ≤ 1.5 ULN OR creatinine clearance ≥ 40 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 2 x ULN for Gilbert disease or leukemic infiltration); AST/ALT ≤ 2.5 x ULN
Cardiac function
No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months; No impaired cardiac function (LVEF < 45% or NYHA stage III or IV CHF); No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states unless a permanent pacemaker has been implanted; QTcF ≤ 470 msec
No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration. No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) < 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF). QT interval by Fridericia's correction formula (QTcF) ≤ 470 msec. Total bilirubin, serum ≤ 1.5 x upper limit of normal (ULN)* (Except in the event of: 1) Gilbert disease, in which case total bilirubin must be ≤ 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be ≤ 2 x ULN). Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 x ULN. Creatinine, serum ≤ 1.5 ULN OR creatinine clearance ≥ 40 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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