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RECRUITINGPHASE1

Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL

A Phase 1 Study With a Pilot Expansion Phase of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) for Relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL)

NCT06863259•Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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

Age

1 - 39 years

Sex

ALL

Healthy Volunteers

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 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 Ph+ ALL must have had at least two prior therapy attempts and failed all available tyrosine kinase inhibitors.
•Prior Therapy:
•\- Cytotoxic chemotherapy:
+24 more criteria

Exclusion Criteria

•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.
•Concomitant Medications:
•Investigational drugs: patients who are currently receiving another investigational drug.
•Anti-cancer agents: Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy).
•Patients \> 10 kg AND \> 24months may receive azole antifungals (See altered venetoclax dosing provided for patients on azoles).
•Infection:
•Patients with known HIV, hepatitis B or C infections. Testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient.
•Patients who have an active uncontrolled infection defined as:
+10 more criteria

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

May 21, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2029

Last Updated

February 18, 2026

Enrollment

ESTIMATED participants

Conditions

B-cell Acute Lymphoblastic Leukemia

Interventions

Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone

DRUG

Contacts

Jeremy Rubinstein, MD, PhD

CONTACT

513-636-2799 jeremy.rubinstein@cchmc.org

Site Primary Contact Cancer line

CONTACT

513-636-2799 cancer@cchmc.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL

Inclusion Criteria

Exclusion Criteria

Clinical Study of SYNCAR-100 in the Treatment of Relapsed/Refractory Acute B-Lymphoblastic Leukemia

Long-term Follow up Local Registry Study of Kymriah in South Korea

A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia

CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma