NCT04321161 is a EARLY_PHASE1 clinical trial of Bicanorm in Acute Myeloid Leukemia, in Relapse, sponsored by University of Freiburg.

Who is sponsoring NCT04321161?

NCT04321161 is sponsored by University of Freiburg.

What drugs are being tested in NCT04321161?

Interventions in NCT04321161: Bicanorm.

What condition does NCT04321161 study?

NCT04321161 studies Acute Myeloid Leukemia, in Relapse.

Is NCT04321161 still recruiting?

NCT04321161 is currently completed. Last updated 25 March 2020.

Last reviewed 2020-03-25 · How we verify

NCT04321161

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

Analysis of T Cell Metabolism in Relapsed AML Patients With DLIs and Bicanorm Treatment

Completed EARLY_PHASE1 Last updated 25 March 2020

What this trial tests

EARLY_PHASE1 trial testing Bicanorm in Acute Myeloid Leukemia, in Relapse in 10 participants. Completed in 18 March 2020.

Timeline

25 February 2020

Primary endpoint
18 March 2020

18 March 2020

Quick facts

Lead sponsor	University of Freiburg
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	25 February 2020
Primary completion	18 March 2020
Estimated completion	18 March 2020
Sites	1 location across Germany

Drugs / interventions tested

Bicanorm — full drug profile →

Conditions studied

Acute Myeloid Leukemia, in Relapse — all drugs for Acute Myeloid Leukemia, in Relapse →

Sponsor

University of Freiburg

Who can join

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

Sponsor's own description

In this study, the outcomes of relapsed AML patients receiving DLIs and Bicanorm (Sodium bicarbonate) were analyzed including T cell metabolism and immune phenotype.

Publications & conference data

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

Metabolic reprogramming of donor T cells enhances graft-versus-leukemia effects in mice and humans.
Uhl FM, Chen S, O'Sullivan D, Edwards-Hicks J, et al · · 2020 · cited 110× · PMID 33115954 · DOI 10.1126/scitranslmed.abb8969
Metabolism of Innate Immune Cells in Cancer.
Talty R, Olino K. · · 2021 · cited 41× · PMID 33670082 · DOI 10.3390/cancers13040904
Biology of post-transplant relapse: actionable features.
Orofino G, Vago L. · · 2024 · cited 3× · PMID 39644002 · DOI 10.1182/hematology.2024000588

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia, in Relapse

Currently open trials in the same condition.

NCT04716452 — Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
NCT06372717 — A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS · Phase 1 · recruiting
NCT06201247 — Off-the-shelf CD123 CAR-NK for R/R AML · EARLY_PHASE1 · recruiting
NCT06125652 — Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML) · Phase 1, PHASE2 · recruiting
NCT06017258 — A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia · Phase 1 · recruiting

Other University of Freiburg trials

Trials by the same sponsor.

NCT07517731 — Using Digital Technology for the Prevention of Aedes-Borne Diseases in Colombian Communities · NA · completed
NCT07053631 — Investigation of a New Window Into Intracranial Pressure: Venous Occlusion Pressure of the Isolated Periorbital Vein · NA · recruiting
NCT06301412 — Combination of Hypothermia and Thrombectomy in Acute Stroke · Phase 3 · recruiting
NCT06074874 — Intestinal Biomarker Analysis After ECP for ICI Colitis · completed
NCT05414552 — ECP for Immune-related Adverse Events After Checkpoint Inhibitor Treatment · completed

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 NCT04321161 (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 University of Freiburg
Last refreshed: 25 March 2020

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/NCT04321161.

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