NCT04982354 is a Phase 1, PHASE2 clinical trial of CPX-351 in Acute Myeloid Leukemia, sponsored by Guenther Koehne.

Who is sponsoring NCT04982354?

NCT04982354 is sponsored by Guenther Koehne.

What drugs are being tested in NCT04982354?

Interventions in NCT04982354: CPX-351, Midostaurin, Busulfan, Melphalan, Fludarabine, CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor.

What condition does NCT04982354 study?

NCT04982354 studies Acute Myeloid Leukemia.

Is NCT04982354 still recruiting?

NCT04982354 is currently withdrawn. Last updated 1 October 2024.

Last reviewed 2024-10-01 · How we verify

NCT04982354

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

Withdrawn Phase 1, PHASE2 Last updated 1 October 2024

What this trial tests

Phase 1, PHASE2 trial testing CPX-351 in Acute Myeloid Leukemia. Withdrawn.

Timeline

5 July 2022

Primary endpoint
1 August 2031

1 August 2032

Quick facts

Lead sponsor	Guenther Koehne
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	5 July 2022
Primary completion	1 August 2031
Estimated completion	1 August 2032
Sites	1 location across United States

Drugs / interventions tested

CPX-351
Midostaurin (MIDOSTAURIN) — full drug profile →
Busulfan — full drug profile →
Melphalan
Fludarabine (FLUDARABINE) — full drug profile →
CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Guenther Koehne — full company profile →

Who can join

Adults 18 to 74, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (CPX-351) in combination with a FLT3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk FLT3 mutated acute myeloid leukemia (AML) and subsequent CD34+-selected allogeneic stem cell transplant from HLA compatible related or unrelated donors.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Lipid-engineered nanotherapeutics for cancer management.
Fernandez-Fernandez A, Manchanda R, Kumari M. · · 2023 · cited 21× · PMID 37033603 · DOI 10.3389/fphar.2023.1125093
How I treat secondary acute myeloid leukemia.
Green SD, Wang ES. · · 2025 · cited 8× · PMID 39356870 · DOI 10.1182/blood.2024024011
CPX-351 in <i>FLT3</i>-mutated acute myeloid leukemia.
Andrews C, Pullarkat V, Recher C. · · 2023 · cited 2× · PMID 38044999 · DOI 10.3389/fonc.2023.1271722
Implementation of Natural Products and Derivatives in Acute Myeloid Leukemia Management: Current Treatments, Clinical Trials and Future Directions.
Merhi F, Dauzonne D, Bauvois B. · · 2026 · PMID 41595108 · DOI 10.3390/cancers18020185

Verify or expand the search:

Other trials of CPX-351

Trials testing the same drug.

NCT07008638 — Phase I/II Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53- · Phase 1, PHASE2 · recruiting
NCT05829434 — Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS · Phase 2 · withdrawn
NCT04992949 — Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm · Phase 2 · completed
NCT05169307 — CPX-351 Real-World Effectiveness and Safety Study · completed
NCT04668885 — CPX-351 as a Novel Approach for the Treatment of Older Patients With AML and MDS · Phase 2 · active not recruiting

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other Guenther Koehne trials

Trials by the same sponsor.

NCT05350163 — T-cell Receptor α/β Depleted Donor Lymphocyte Infusion · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04982354 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Guenther Koehne
Last refreshed: 1 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04982354.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing