NCT03555955 is a Phase 1 clinical trial of CPX-351 in Hematologic Malignancy, sponsored by Jazz Pharmaceuticals.

Who is sponsoring NCT03555955?

NCT03555955 is sponsored by Jazz Pharmaceuticals.

What drugs are being tested in NCT03555955?

Interventions in NCT03555955: CPX-351, CPX-351.

What condition does NCT03555955 study?

NCT03555955 studies Hematologic Malignancy, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes.

Is NCT03555955 still recruiting?

NCT03555955 is currently completed. Last updated 22 July 2021.

Last reviewed 2021-07-22 · How we verify

NCT03555955

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

A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351

Completed Phase 1 Last updated 22 July 2021

What this trial tests

Phase 1 trial testing CPX-351 in Hematologic Malignancy in 21 participants. Completed in 26 May 2021.

Timeline

20 November 2018

Primary endpoint
26 May 2021

26 May 2021

Quick facts

Lead sponsor	Jazz Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	20 November 2018
Primary completion	26 May 2021
Estimated completion	26 May 2021
Sites	13 locations across Canada, United States

Drugs / interventions tested

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

Conditions studied

Hematologic Malignancy — all drugs for Hematologic Malignancy →
Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Acute Lymphocytic Leukemia — all drugs for Acute Lymphocytic Leukemia →
Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →

Sponsor

Jazz Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Hematologic Malignancy or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.

Publications & conference data

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

Targeting Approaches of Nanomedicines in Acute Myeloid Leukemia.
Huang X, Lin H, Huang F, Xie Y, et al · · 2019 · cited 17× · PMID 31853234 · DOI 10.1177/1559325819887048
CPX-351 Pharmacokinetics and Safety in Adults with Hematologic Malignancies and Renal Function Impairment: Phase 1 Trial.
Solomon SR, Powell BL, Koprivnikar J, Lai C, et al · · 2024 · cited 2× · PMID 38473278 · DOI 10.3390/cancers16050915

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 Hematologic Malignancy

Currently open trials in the same condition.

NCT06856226 — Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing · recruiting
NCT07511127 — Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT · Phase 3 · recruiting
NCT07413991 — Expressive Writing Program Among Young Adults With Blood Cancer · NA · active not recruiting
NCT06487247 — HEME Home Transfusion Program · NA · recruiting
NCT07035938 — T-cell Developmental Status in Patients With Malignant Hematological Tumors · recruiting

Other Jazz Pharmaceuticals trials

Trials by the same sponsor.

NCT07533942 — A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma · Phase 2 · not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting
NCT07377539 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants · Phase 1 · not yet recruiting
NCT07282587 — Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma · Phase 2 · recruiting
NCT07233239 — A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment · Phase 1 · 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 NCT03555955 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Jazz Pharmaceuticals
Last refreshed: 22 July 2021

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/NCT03555955.

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