NCT03059615 is a Phase 2 clinical trial of Nerofe in Acute Myelogenous Leukemia, sponsored by Immune System Key Ltd.

Who is sponsoring NCT03059615?

NCT03059615 is sponsored by Immune System Key Ltd.

What drugs are being tested in NCT03059615?

Interventions in NCT03059615: Nerofe, Doxorubicin.

What condition does NCT03059615 study?

NCT03059615 studies Acute Myelogenous Leukemia, Myelodysplastic Syndromes.

Is NCT03059615 still recruiting?

NCT03059615 is currently withdrawn. Last updated 31 July 2020.

Last reviewed 2020-07-31 · How we verify

NCT03059615

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

A Phase 2a, Open-Label, Two Stage Study of Nerofe or Nerofe With Doxorubicin in Subjects With AML or MDS

Withdrawn Phase 2 Last updated 31 July 2020

What this trial tests

Phase 2 trial testing Nerofe in Acute Myelogenous Leukemia. Withdrawn.

Timeline

25 October 2018

Primary endpoint
26 July 2020

26 July 2020

Quick facts

Lead sponsor	Immune System Key Ltd
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Start date	25 October 2018
Primary completion	26 July 2020
Estimated completion	26 July 2020
Sites	2 locations across Israel

Drugs / interventions tested

Nerofe — full drug profile →
Doxorubicin (doxorubicin) — full drug profile →

Conditions studied

Acute Myelogenous Leukemia — all drugs for Acute Myelogenous Leukemia →
Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Immune System Key Ltd — full company profile →

Who can join

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

Sponsor's own description

This is a Phase 2a, Open-label, one arm study in which the eligible patients will be treated with IV Nerofe, three times a week in 28 days cycles (up to 12 cycles). Evaluation will include safety procedures, blood level of study drug in certain time points, immune system response and tests checking the mechanism of the drug action.

Publications & conference data

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

Molecular targeting in acute myeloid leukemia.
Lim SH, Dubielecka PM, Raghunathan VM. · · 2017 · cited 32× · PMID 28851395 · DOI 10.1186/s12967-017-1281-x
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 Nerofe

Trials testing the same drug.

NCT04365179 — Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML · Phase 1 · 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 Immune System Key Ltd trials

Trials by the same sponsor.

NCT04365179 — Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML · Phase 1 · recruiting
NCT03634150 — Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cance · Phase 1, PHASE2 · withdrawn

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 NCT03059615 (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 Immune System Key Ltd
Last refreshed: 31 July 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/NCT03059615.

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