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COMPLETED Phase 2

Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia

NCT03575325 · View on ClinicalTrials.gov ↗

Study Summary

This study involves Vyxeos (CPX-351), a formulation of a fixed combination of the two anti-tumor drugs, cytarabine and daunorubicin that will be given as an infusion over 90 minutes. This study will use what is called a "liposome" injection. This is a special fat capsule (called a liposome) that surrounds the cytarabine and daunorubicin and protects the drugs from being eliminated/destroyed by the body.

Interventions

  • DRUG CPX-351

Study Locations (1)

Florida

  • H. Lee Moffitt Cancer Center and Research Institute — Tampa

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2018-10-11
Est. Completion 2023-09-14
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03575325

The ClinicalTrials.gov registry entry for NCT03575325 describes a study currently listed as completed. It is categorized as Phase 2, 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 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 562 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention — of which CPX-351 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: NCT03575325 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. 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 NCT03575325 about?

NCT03575325 is a clinical study titled "Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia". This study involves Vyxeos (CPX-351), a formulation of a fixed combination of the two anti-tumor drugs, cytarabine and daunorubicin that will be given as an infusion over 90 minutes. This study will use what is called a "liposome" injection. This is a special fat capsule (called a liposome) that sur...

What is the current status of trial NCT03575325?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2018-10-11. Estimated completion is 2023-09-14.

What conditions does trial NCT03575325 study?

This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia, Lymphoid 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 NCT03575325?

The interventions under investigation include: CPX-351 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03575325?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 562 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03575325 being conducted?

This trial has 1 study location across Florida. 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