Actively Recruiting
Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-02-18
28
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL) with more than 5% bone marrow blasts
- At least 20% of leukemic blasts must express CD22 at relapse
- Patients with second or later relapse, or first relapse less than 24 months from diagnosis, or first or later relapse if over 18 years old
- Patients with primary refractory disease defined as more than 1% bone marrow blasts after frontline chemotherapy
- Patients with relapse after hematopoietic stem cell transplant (HSCT) or CAR-T therapy
- Patients with Ph+ ALL must have failed all available tyrosine kinase inhibitors after at least two prior therapies
- At least 14 days from last systemic myelosuppressive chemotherapy
- At least 21 days from last antibody treatment (except 3 days for blinatumomab)
- At least 14 days from local radiotherapy or 3 months if cranial/craniospinal or total body irradiation
- At least 90 days from stem cell transplant and 30 days from donor lymphocyte infusion with no active graft vs. host disease
- At least 30 days from last CAR-T infusion
- Prior Inotuzumab Ozogamicin exposure limited to 2.1 mg/m2 and at least 90 days from last dose
- Prior Venetoclax exposure allowed if at least 30 days from last dose
- Age 1 to 39.99 years at enrollment
- Karnofsky or Lansky performance status of 50% or higher
- Adequate kidney function with estimated GFR of at least 50 mL/min/1.73m2
- Adequate liver function with direct bilirubin ≤ 1.5 times upper limit of normal and ALT < 2.5 times upper limit of normal
- Patients with prior or concurrent malignancies that do not interfere with study assessments are eligible
You will not qualify if you...
- History of sinusoidal obstruction syndrome (SOS)
- Isolated central nervous system (CNS), testicular, or other isolated extramedullary relapse
- CNS3 disease at enrollment
- Currently receiving other investigational drugs or anti-cancer agents (except hydroxyurea or intrathecal chemotherapy)
- Receiving anti-graft versus host disease (GVHD) or anti-rejection medications within 3 half-lives
- Known HIV, hepatitis B or C infections
- Active uncontrolled infections including positive bacterial blood culture or fever with infection within 48 hours of enrollment
- Positive fungal culture within 30 days or active treatment for invasive fungal infection
- Active viral or protozoal infection requiring intravenous treatment
- Known genetic syndromes affecting bone marrow such as blood syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachmann-Diamond syndrome
- Pregnant or breastfeeding females or those not agreeing to contraception requirements
- Patients who have not recovered from prior anti-cancer therapy toxicities above grade 2 (except alopecia)
- History of allergic reactions to venetoclax or inotuzumab ozogamicin or similar compounds
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
J
Jeremy Rubinstein, MD, PhD
CONTACT
S
Site Primary Contact Cancer line
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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