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NCT04990102 · ClinicalTrials.gov registry record · Phase 1

Phase IB/II of CPX-351 for Relapse Prevention in AML

A Phase 1 study of Acute Myeloid Leukemia (AML) in Remission, sponsored by Georgetown University.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
3
Study locations

NCT04990102: Recruiting Phase 1 study of Acute Myeloid Leukemia (AML) in Remission, sponsored by Georgetown University.

NCT04990102 is a Phase 1 study of Acute Myeloid Leukemia (AML) in Remission that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04990102, a Phase 1 study of Acute Myeloid Leukemia (AML) in Remission, is actively recruiting participants, sponsored by Georgetown University.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
3
Study locations

Study Summary

This is a phase IB/II study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerated dose will be used for the phase II expansion portion of the study.

Primary Outcome

Number of subjects with Dose Limiting toxicities will be used to determine the recommended phase II dose of CPX-351 to be used in the maintenance setting for newly diagnosed AML in complete remission.

Interventions

  • DRUG CPX-351

Study Locations (3)

District of Columbia

  • Georgetown Lombardi Comprehensive Cancer Center - Washington D.C.

New Jersey

  • John Theurer Cancer Center at Hackensack University Medical Center - Hackensack

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2023-05-22
Est. Completion 2026-12
Phase Phase 1
Georgetown University

227 total trials

What NCT04990102 shows while recruiting

NCT04990102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 1 condition, with Acute Myeloid Leukemia (AML) in Remission appearing as the primary indexed condition, and to 1 intervention - of which CPX-351 is the first listed.

NCT04990102 reports a single indexed study location in District of Columbia, New Jersey, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04990102 about?

NCT04990102 is a clinical study titled "Phase IB/II of CPX-351 for Relapse Prevention in AML". This is a phase IB/II study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerat...

What is the current status of trial NCT04990102?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-05-22. Estimated completion is 2026-12.

What conditions does trial NCT04990102 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML) in Remission.

What interventions are being tested in trial NCT04990102?

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

Who is sponsoring clinical trial NCT04990102?

This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04990102 being conducted?

This trial has 3 study locations across District of Columbia, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04990102's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04990102, the US trial registry maintained by the National Library of Medicine. NCT04990102 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.