NCT06863259 Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL
| NCT ID | NCT06863259 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | B-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2025-05-21 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Diagnosis: \- Patients must have relapsed B-ALL \> 5 % bone marrow blasts with or without extramedullary disease. * 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. * Patients with one of the following: * 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
Frequently Asked Questions
Who can join the NCT06863259 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 39 Years, studying B-cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06863259 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06863259 currently recruiting?
Yes, NCT06863259 is actively recruiting participants. Visit ClinicalTrials.gov or contact Children's Hospital Medical Center, Cincinnati to inquire about joining.
Where is the NCT06863259 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06863259 clinical trial?
NCT06863259 is sponsored by Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 28 participants.
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