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NCT00756912
A Phase I, Open-Label, Dose Escalation Study of Eritoran (E5564) Administered IV Over 14 Days Prior to and During Bone Marrow Engraftment in BMT Patients Who Have Received Myeloablative Conditioning Treatment and Are Receiving Bone Marrow or Stem Cells From Matched Related Donors
Phase 1 trial testing E5564 in Leukemia in 30 participants. Terminated before completion.
1 November 2008
Quick facts
| Lead sponsor | Eisai Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 1 September 2008 |
| Primary completion | 1 November 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- E5564 — full drug profile →
Conditions studied
- Leukemia — all drugs for Leukemia →
Sponsor
Eisai Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Leukemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and assessments will be done daily.
Time frame: Performed daily through Day 28, with follow-up every other week to Day 100 and at 1 year post-transplant.
Sponsor's own description
This is a study designed to assess the safety of administration of up to 3 dose levels of eritoran in subjects undergoing or scheduled to undergo allogeneic bone marrow transplant (BMT). An allogeneic BMT is the transplantation of blood stem cells taken from the bone marrow or blood of another person.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Eritoran tetrasodium (E5564) treatment for sepsis: review of preclinical and clinical studies.
Barochia A, Solomon S, Cui X, Natanson C, et al · · 2011 · cited 141× · PMID 21323610 · DOI 10.1517/17425255.2011.558190 -
Toll-Like Receptors as a Therapeutic Target in the Era of Immunotherapies.
Farooq M, Batool M, Kim MS, Choi S. · · 2021 · cited 70× · PMID 34671606 · DOI 10.3389/fcell.2021.756315 -
Targeting toll-like receptor 4 signalling pathways: can therapeutics pay the toll for hypertension?
Nunes KP, de Oliveira AA, Mowry FE, Biancardi VC. · · 2019 · cited 46× · PMID 29981161 · DOI 10.1111/bph.14438 -
Damage-associated molecular patterns (DAMPs) in diseases: implications for therapy.
Lin H, Xiong W, Fu L, Yi J, et al · · 2025 · cited 17× · PMID 40877572 · DOI 10.1186/s43556-025-00305-3
Verify or expand the search:
- PubMed search for NCT00756912
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Eisai Inc. trials
Trials by the same sponsor.
- NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
- NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
- NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
- NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
- NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00756912 (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 Eisai Inc.
- Last refreshed: 10 July 2014
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/NCT00756912.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing