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NCT03575325 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 2
Development phase
11
Enrollment target
1
Study location

NCT03575325 is a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 11 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03575325, a Phase 2 study of Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 2
Development phase
11 participants
Enrollment target
1
Study location

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

What the Registry Record Tells You About NCT03575325

The ClinicalTrials.gov registry entry for NCT03575325 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (97% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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.

NCT03575325 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

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.

What interventions are being tested in trial NCT03575325?

The interventions under investigation include: CPX-351 (DRUG).

Who is sponsoring clinical trial NCT03575325?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

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.

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

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