NCT04109690 is a Phase 1, PHASE2 clinical trial of CPX-351 in MDS, sponsored by Yale University.

Who is sponsoring NCT04109690?

NCT04109690 is sponsored by Yale University.

What drugs are being tested in NCT04109690?

Interventions in NCT04109690: CPX-351.

Is NCT04109690 still recruiting?

NCT04109690 is currently withdrawn. Last updated 24 January 2022.

Last reviewed 2022-01-24 · How we verify

NCT04109690

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

CPX-351 in Patients Treated for Higher-risk Myelodysplastic Syndromes Experiencing Hypomethylating Agent Failure.

Withdrawn Phase 1, PHASE2 Last updated 24 January 2022

What this trial tests

Phase 1, PHASE2 trial testing CPX-351 in MDS. Withdrawn.

Timeline

30 December 2019

Primary endpoint
27 July 2021

27 July 2021

Quick facts

Lead sponsor	Yale University
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	30 December 2019
Primary completion	27 July 2021
Estimated completion	27 July 2021
Sites	1 location across United States

Drugs / interventions tested

CPX-351 (cpx-351) — full drug profile →

Conditions studied

MDS — all drugs for MDS →

Sponsor

Yale University

Who can join

Adults 18 to 78, any sex, with MDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed study is of a Liposomal formulation of cytarabine and daunorubicin (CPX-351) in patients treated for higher-risk myelodysplastic syndromes (MDS) experiencing hypomethylating agent failure.

Publications & conference data

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

Current challenges and unmet medical needs in myelodysplastic syndromes.
Platzbecker U, Kubasch AS, Homer-Bouthiette C, Prebet T. · · 2021 · cited 67× · PMID 34045662 · DOI 10.1038/s41375-021-01265-7
Risk-Adapted, Individualized Treatment Strategies of Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML).
Bewersdorf JP, Zeidan AM. · · 2021 · cited 21× · PMID 33807279 · DOI 10.3390/cancers13071610

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
NCT04982354 — Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia · Phase 1, PHASE2 · 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

Other recruiting trials for MDS

Currently open trials in the same condition.

NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML · NA · recruiting
NCT06717958 — Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute M · Phase 2 · recruiting
NCT06972641 — Molecular Genetics Guide the Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation · Phase 2, PHASE3 · recruiting
NCT07006025 — A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS) · Phase 1 · recruiting
NCT06895538 — Comparison of ATLG and ATG for Immune Reconstitution After Allo-HSCT for Hematologic Malignancy · recruiting

Other Yale University trials

Trials by the same sponsor.

NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting

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 NCT04109690 (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 Yale University
Last refreshed: 24 January 2022

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/NCT04109690.

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