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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 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. The trial reports 3 study locations across 3 states.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-05-22 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04990102
The ClinicalTrials.gov registry entry for NCT04990102 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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