The goal of this clinical trial is to learn if the combination of drugs Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) are safe to treat relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL) in pediatric and adult patients. It will also learn if these drugs are well tolerated. The main questions it aims to answer are:
Is the drug combination of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) safe when given to patients?
What medical problems do patients taking IoVeX experience?
Participants will:
Receive this combination of drugs for 1 cycle which is 28 days at various timepoints. If participants tolerate cycle 1 they will be eligible to continue to cycle 2 which is also 28 days.
Have checkups and tests at the beginning of the study and throughout the course of each cycle.
At least 20% of leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by flow cytometry of a bone marrow aspirate. In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be obtained due to patient clinical status, then flow cytometry of peripheral blood specimens may be substituted if the patient has > 1,000/µL circulating blasts. Alternatively, CD22 expression may be documented by immunohistochemistry of a relapse bone marrow biopsy specimen.
2nd or greater relapse OR first relapse less than 24 months from diagnosis OR first or greater relapse in patients over 18.
Primary refractory disease: defined as > 1% bone marrow blasts by flow MRD after at least 2 courses of frontline chemotherapy. Patients who receive 2 courses of chemotherapy and 1 course of blinatumomab are also eligible, but no further treatment attempts beyond that are permitted.
Any relapse after HSCT or CAR-T therapy.
Patients with any prior history of SOS irrespective of severity.
Patients with isolated CNS, testicular, or any other isolated extramedullary site of relapse.
Patients with CNS3 disease at time of enrollment regardless of marrow involvement.
Investigational drugs: patients who are currently receiving another investigational drug.