NCT03904251 is a Phase 1 clinical trial of Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia, sponsored by Jonsson Comprehensive Cancer Center.

Who is sponsoring NCT03904251?

NCT03904251 is sponsored by Jonsson Comprehensive Cancer Center.

What drugs are being tested in NCT03904251?

Interventions in NCT03904251: Gemtuzumab Ozogamicin, Liposome-encapsulated Daunorubicin-Cytarabine.

What condition does NCT03904251 study?

NCT03904251 studies Acute Myelogenous Leukemia.

Is NCT03904251 still recruiting?

NCT03904251 is currently terminated. Last updated 18 November 2023.

Last reviewed 2023-11-18 · How we verify

NCT03904251

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

CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia

Terminated Phase 1 Last updated 18 November 2023

What this trial tests

Phase 1 trial testing Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia in 13 participants. Terminated before completion.

Timeline

18 July 2019

Primary endpoint
25 October 2023

25 October 2023

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	18 July 2019
Primary completion	25 October 2023
Estimated completion	25 October 2023
Sites	5 locations across United States

Drugs / interventions tested

Gemtuzumab Ozogamicin (Gemtuzumab Ozogamicin) — full drug profile →
Liposome-encapsulated Daunorubicin-Cytarabine — full drug profile →

Conditions studied

Acute Myelogenous Leukemia — all drugs for Acute Myelogenous Leukemia →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Acute Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia that has come back after it was previously in remission. CPX-351 is a chemotherapy, which works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to chemotherapy called calicheamicin. Gemtuzumab attaches to CD33 (transmembrane receptor) positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving CPX-351 and gemtuzumab ozogamicin may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.

Publications & conference data

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

Natural killer cell-based immunotherapy for acute myeloid leukemia.
Xu J, Niu T. · · 2020 · cited 83× · PMID 33287858 · DOI 10.1186/s13045-020-00996-x
Update on the role of gemtuzumab-ozogamicin in the treatment of acute myeloid leukemia.
Swaminathan M, Cortes JE. · · 2023 · cited 28× · PMID 36845850 · DOI 10.1177/20406207231154708
New drugs before, during, and after hematopoietic stem cell transplantation for patients with acute myeloid leukemia.
Mohty R, El Hamed R, Brissot E, Bazarbachi A, et al · · 2023 · cited 28× · PMID 36722403 · DOI 10.3324/haematol.2022.280798
ELN risk stratification and outcomes in secondary and therapy-related AML patients consolidated with allogeneic stem cell transplantation.
Jentzsch M, Grimm J, Bill M, Brauer D, et al · · 2021 · cited 28× · PMID 33208914 · DOI 10.1038/s41409-020-01129-1
Antibody-Drug Conjugates for the Treatment of Acute Pediatric Leukemia.
Stokke JL, Bhojwani D. · · 2021 · cited 19× · PMID 34441852 · DOI 10.3390/jcm10163556
Single-agent and combination biologics in acute myeloid leukemia.
Richard-Carpentier G, DiNardo CD. · · 2019 · cited 18× · PMID 31808888 · DOI 10.1182/hematology.2019000059
Targeted Drug Delivery and Theranostic Strategies in Malignant Lymphomas.
Etrych T, Braunova A, Zogala D, Lambert L, et al · · 2022 · cited 17× · PMID 35158894 · DOI 10.3390/cancers14030626
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

Verify or expand the search:

Other trials of Gemtuzumab Ozogamicin

Trials testing the same drug.

NCT06917911 — Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin · Phase 2 · not yet recruiting
NCT05564390 — MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Wi · Phase 2 · recruiting
NCT04915612 — Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patient · Phase 1 · completed
NCT04207190 — Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · completed
NCT04293562 — A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed A · Phase 3 · recruiting

Other recruiting trials for Acute Myelogenous Leukemia

Currently open trials in the same condition.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06904482 — Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood · Phase 2 · recruiting
NCT06680661 — ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis · Phase 2 · recruiting
NCT06131801 — Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution · recruiting
NCT05974150 — Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia · recruiting

Other Jonsson Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio · Phase 3 · not yet recruiting
NCT07517211 — A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, · not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
NCT07468903 — Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer · 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 NCT03904251 (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 Jonsson Comprehensive Cancer Center
Last refreshed: 18 November 2023

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/NCT03904251.

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