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LeukemiaPhase 1NCT00756912

A 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

A Phase 1 study testing E5564 in people with Leukemia, run by Eisai Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Leukemia
What is being tested?
E5564
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Sep 2008to Nov 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subjects must meet all of the inclusion criteria outlined below in order to be eligible to participate in this study:
  • Adult subjects (aged 18 to 55 years old) undergoing or scheduled to undergo myeloablative conditioning and allogeneic BMT, or stem cells from matched donors.
  • Subjects using either busulfan or total body irradiation (TBI) containing regimens for BMT for the treatment of malignant and nonmalignant diseases. For example:
  • Cyclophosphamide and Total Body Irradiation (CY-TBI) with a TBI dose of at least 1200 cGy of fractionated TBI
  • Etoposide and Total Body Irradiation (VP16-TBI) with a TBI dose of at least 1200 cGy of fractionated TBI
  • Busulfan and cyclophosphamide (BU-CY) with at least 14 mg/kg busulfan orally or 11.2 mg/kg busulfan intravenously (14 x 0.8 correction factor) or a targeted busulfan dosing strategy aimed at a serum concentration greater than 600 ng/mL at steady state.
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  • Leukemia patients with:
  • acute myelogenous leukemia (AML)
  • acute lymphoblastic leukemia (ALL) in first or subsequent complete remission
  • chronic myelogenous leukemia (CML) in first or subsequent chronic phase or in accelerated phase
  • myelodysplastic syndrome (MDS) patients.
  • OR
  • Subjects with non-Hodgkin's lymphoma who are in complete remission as determined by physical exam, CT and PET scans, and are otherwise considered candidates for allogeneic BMT as judged by the treating institution
  • Available matched related CD34+ stem cells (target cell dose between 2 x 10^6/kg and 10 x 10^6/kg (actual body weight)) for transplantation (matched at 6/6 HLA at Class I HLA-A and B and Class II HLA-DRBI).
  • Sex distribution: men or nonpregnant women. Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (hCG) or urine assay prior to eritoran treatment or prior to the beginning of conditioning treatment. Menopausal women must have been amenorrheic for at least 12 months.
  • Race: any.
  • Has signed informed consent before any study-specific procedures are performed.

Who cannot join

  • Unwilling or unable to agree to be fully evaluated for all follow-up visits. The subject or subject's representative and the study staff should agree to perform all study assessments even if the subject is discharged from the hospital.
  • Seropositive for human immunodeficiency virus (HIV); testing is not needed if already performed (documentation required) as part of screening for conditioning treatment.
  • Subjects with a documented or possible systemic infection, or suspected of having a medically significant viral, bacterial, or fungal infection at the beginning of treatment on Day -3.
  • Have taken any investigational medications (ie, not approved by the FDA for any indication) within the 30-day period prior to enrollment into the study.
  • Karnofsky Performance Status (KPS) <60%.
  • Have previously received a bone marrow or stem cell transplant.
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  • Are to receive T-cell depleted BMT or stem cell infusions.
  • Are pregnant or lactating.
  • Known sensitivity to eritoran or its excipients.
  • Prior malignancies treated with a curative intent of < 5 years will not be allowed. Previously treated cancer with a curative intent of > 5 years will be allowed.
  • Legal incapacity.
  • Any of the following laboratory parameters within 2 days prior to the beginning of treatment on Day -3:
  • direct bilirubin ≥ 2x ULN
  • liver function tests (ALT or AST) with values ≥ 3x ULN
  • serum creatinine ≥ 2x ULN
  • Subjects who are enrolled in other interventional, investigational protocols. As aGvHD is likely to only occur after treatment with eritoran is completed, investigational treatments for Grades III and IV aGvHD may be allowed and should be discussed with the Sponsor.
  • Subjects with a history of or with current pulmonary disease with forced vital capacity (FVC) or forced expiratory volume in 1 second (FEV1) < 60% predicted (corrected for hemoglobin).
  • Subjects with a history of a cardiac ejection fraction < 45%, or with marked screening or baseline prolongation QT/QTc interval (QTc interval > 470 mSec).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Western Reserve University School of Medicine

    Cleveland, Ohio, 44106-7728

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

Please note: in the original protocol, the study phase is listed as "Phase Ib", although the Official Title reads "Phase I".

Conditions
Leukemia
Being tested
E5564
Keywords
ANC, BMT, graft versus leukemia, graft vs. host disease, MD2 (endotoxin binding-protein), undergo allogeneic BMT, myeloablative, conditioning, therapy
Medical subject headings
Leukemia, Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E5564Drug

    Also called Eritoran

    Three dose levels of Eritoran IV over 14 days for a total of 32, 96, and 224 mg over 14 days.

Study groups in NCT00756912
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: E5564

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and assessments will be done daily.

    Measured: Performed daily through Day 28, with follow-up every other week to Day 100 and at 1 year post-transplant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionNov 2008

Why it stopped: This study was terminated in November 2008 due to "a business decision (resources)".

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00756912
Sponsor's protocol ID
E5564-A001-102
Status last verified
Jul 2014
First submitted
18 Sep 2008
Last updated
11 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E5564 in people with Leukemia, run by Eisai Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study was terminated in November 2008 due to "a business decision (resources)".). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00756912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.

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