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NCT05656248 · ClinicalTrials.gov registry record · Phase 2

Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms

A Phase 2 study of Myeloid Neoplasm, sponsored by St. Jude Children's Research Hospital.

Active
Registry status
Phase 2
Development phase
25
Enrollment target
1
Study location

NCT05656248: Active Phase 2 study of Myeloid Neoplasm, sponsored by St. Jude Children's Research Hospital.

NCT05656248 is a Phase 2 study of Myeloid Neoplasm that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 25 participants, below the 295-participant average among 7 other Myeloid Neoplasm trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05656248, a Phase 2 study of Myeloid Neoplasm, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to learn the effects of treatment with an investigational drug, CPX-351 in patients with secondary myeloid neoplasms (SMNs).

Primary Outcome

The Simon's two-stage minimax design with be used. Complete morphologic remission response (CR) is defined as less than 5% blasts without Auer rods by morphological evaluation of the bone marrow (M1 marrow).

Conditions Studied

Myeloid Neoplasm

Interventions

  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
  • DRUG CPX-351
  • DRUG MHA

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2023-01-17
Est. Completion 2028-08
Phase Phase 2
St. Jude Children's Research Hospital

410 total trials

What the registry record for NCT05656248 still lists

NCT05656248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 295-participant average among 7 other Myeloid Neoplasm trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Myeloid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Allogeneic Hematopoietic Stem Cell Transplantation is the first listed.

NCT05656248 reports a single indexed study location in Tennessee.

Frequently Asked Questions

What is clinical trial NCT05656248 about?

NCT05656248 is a clinical study titled "Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms". The purpose of this study is to learn the effects of treatment with an investigational drug, CPX-351 in patients with secondary myeloid neoplasms (SMNs).

What is the current status of trial NCT05656248?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2023-01-17. Estimated completion is 2028-08.

What conditions does trial NCT05656248 study?

This clinical trial studies the following conditions: Myeloid Neoplasm.

What interventions are being tested in trial NCT05656248?

The interventions under investigation include: Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), CPX-351 (DRUG), MHA (DRUG).

Who is sponsoring clinical trial NCT05656248?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05656248 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT05656248, the US trial registry maintained by the National Library of Medicine. NCT05656248 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.