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ACTIVE NOT RECRUITING Phase 1

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

NCT05192889 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase I/II clinical trial evaluating the activity of combination chemotherapy with venetoclax and navitoclax in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) and assessing the combination dose of venetoclax combinations with either blinatumomab for CD19-positive patients or navitoclax and high-dose cytarabine for CD19-negative patients. Primary Objectives * To compare Minimal Residual Disease (MRD)-negative CR/CRi rate in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) following Block 1 therapy with venetoclax and navitoclax based reinduction to historical controls. * To identify the recommended phase 2 combination dose (RP2D) of venetoclax based consolidation in novel combinations with a) high-dose cytarabine and navitoclax or b) blinatumomab. Secondary Objectives * To estimate the tolerability and activity of venetoclax based consolidation in novel combinations with a) high-dose cytarabine and navitoclax or b) blinatumomab. * To describe event-free and overall survival in patients treated with this regimen. Exploratory Objectives * To evaluate MRD-negative CR/CRi rates in each prespecified groups: late first relapse B-ALL; early first relapse and second or greater relapse B-ALL; and relapsed T-ALL. * To identify drug sensitivity patterns in patient samples prior to and after receiving combination therapy and evaluate mechanisms of disease resistance/ escape. * To explore immune subsets during and after this regimen. * Evaluate response to therapy in rare relapse patient subsets. * Explore breakthrough infections in children and young adults with relapsed or refractory ALL

Interventions

  • DRUG Venetoclax
  • DRUG Dexamethasone
  • DRUG Vincristine
  • DRUG Calaspargase Pegol
  • DRUG Navitoclax

Study Locations (2)

New York

  • Memorial Sloan Kettering Cancer Center — New York

Tennessee

  • St. Jude Children's Research Hospital — Memphis

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2022-08-25
Est. Completion 2027-02
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05192889

The ClinicalTrials.gov registry entry for NCT05192889 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 441 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Refractory Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Venetoclax is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05192889 reports 2 study locations spanning 2 distinct geographic areas — top geographies include New York, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05192889 about?

NCT05192889 is a clinical study titled "Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax". This is a phase I/II clinical trial evaluating the activity of combination chemotherapy with venetoclax and navitoclax in children with relapsed or refractory acute lymphoblastic leukemia or lymphoma (rALL) and assessing the combination dose of venetoclax combinations with either blinatumomab for CD...

What is the current status of trial NCT05192889?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2022-08-25. Estimated completion is 2027-02.

What conditions does trial NCT05192889 study?

This clinical trial studies the following conditions: Refractory Acute Lymphoblastic Leukemia, Relapsed Acute Lymphoblastic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05192889?

The interventions under investigation include: Venetoclax (DRUG), Dexamethasone (DRUG), Vincristine (DRUG), Calaspargase Pegol (DRUG), Navitoclax (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05192889?

This trial is sponsored by St. Jude Children's Research Hospital, which has 441 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05192889 being conducted?

This trial has 2 study locations across New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial