CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
CPX-351drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03575325
NCT03575325Phase 2Completed
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A Single-Arm, Open-Label Phase 2 Pilot Study of Vyxeos (CPX-351) in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jul 2, 2018·Updated Dec 12, 2024

In Brief

A Phase 2 clinical trial evaluating CPX-351 for Lymphoid Leukemia and 3 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoid Leukemia, Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia, Relapsed Acute Lymphoblastic Leukemia
CountriesUnited States
CollaboratorsJazz Pharmaceuticals

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 2, 2018
Enrollment StartOct 11, 2018
Primary CompletionJun 7, 2021
Study CompletionSep 14, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8 years ago

Interventions

CPX-351drug

The infusion of CPX-351 (cytarabine:daunorubicin) Liposome Injection will be performed through a central venous catheter, using an infusion pump to ensure that the drug is infused over the specified time period.