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Graft Versus Host DiseasePhase 2NCT00639717

Addition of Etanercept and Extracorporeal Photopheresis (ECP) to Standard Graft-Versus-Host Disease (GVHD) Prophylaxis in Stem Cell Transplant

A Phase 2 study testing stem cell transplant, tacrolimus (standard GVHD prophylaxis) and mycophenolate (standard GVHD prophylaxis) in people with Graft Versus Host Disease, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study investigates the benefits and possible risks of adding both etanercept (Enbrel) and ECP (extracorporeal photopheresis) to the conventional preventative (or prophylactic) treatments for graft-versus-host disease (GVHD). Read more about this study

Who is it for?
Any age
Conditions the study is for
Graft Versus Host Disease
What is being tested?
stem cell transplant, tacrolimus (standard GVHD prophylaxis) and mycophenolate (standard GVHD prophylaxis)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
Mar 2009to Apr 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Candidate for unrelated donor (allogeneic) HSCT for hematologic conditions, either malignant or non-malignant.
  • Donor can be unrelated marrow, blood or cord blood.
  • Any disease for which unrelated donor transplant is appropriate is eligible except:
  • Progressive or poorly controlled malignancies for which the likelihood of durable disease control [i.e., patients expected to have at least 6 months PFS from date of transplant] is <25%.
  • This determination of likelihood of durable disease control must take into account the patient's disease status and consideration of the agents and doses used in the reduced intensity conditioning regimen.
  • The determination of adequate disease control will be certified by the PI or designee on the eligibility checklist.
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  • Patients may be consented to this trial based on disease control at the time of consent, but later removed from the trial prior to initiation of transplant conditioning regimen if disease status confirmation between consenting and transplant changes. In the event this occurs these patients will be replaced.
  • Must be receiving a recognized reduced intensity transplant as determined by the University of Michigan Blood and Marrow Transplantation Program.
  • Patients age 50 or older are eligible based on age.
  • Patients may be <50 years old if they are eligible for a reduced intensity conditioning regimen based on disease type (eg, indolent lymphoma) or if comorbidities preclude a full-intensity transplant.
  • Patients must have adequate venous access by either peripheral vein or central line so that ECP can be performed.
  • Patients must be expected to tolerate the fluid shifts associated with ECP. The primary reason for expected intolerance of ECP is small size (ie, <30kg weight), but other factors may also be considered in this determination.

Who cannot join

  • Not a candidate for a reduced intensity transplant conditioning regimen (based on the current U-M BMT program clinical guidelines).
  • Patient has a suitable related donor available for transplant.
  • Karnofsky or Lansky performance status of < 50% at the time of admission for HSCT
  • Patients with evidence of HIV infection or other opportunistic infection including but not limited to Tuberculosis and Histoplasmosis.
  • Patients with active bacterial, fungal or viral infection not responding to treatment.
  • Any medical or psychological conditions that would keep the patient from complying with the protocol and/or would markedly increase the morbidity and mortality from the procedure.
  • Pregnancy.
  • T-cell depleted allograft

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Addition of Etanercept and Extracorporeal Photopheresis to Standard GVHD Prophylaxis in Patients Undergoing Reduced Intensity Unrelated Donor Hematopoietic Stem Cell Transplant

This research study investigates the benefits and possible risks of adding both etanercept (Enbrel) and ECP (extracorporeal photopheresis) to the conventional preventative (or prophylactic) treatments for graft-versus-host disease (GVHD). GVHD is a common, serious, and too often fatal, complication after matched unrelated donor stem cell transplantation, regardless of the pre-transplant conditioning regimen used (full or reduced intensity).

Reduced intensity transplants which employ lower doses of chemotherapy during the conditioning phase of the transplant, are less toxic than full intensity transplants. Reduced intensity transplants may extend the unrelated donor transplant option to older patients or to patients with existing medical conditions or illness, where a full intensity transplant is not possible. To be successful, reduced intensity transplants need to offset any lower effectiveness in killing cancer cells during the conditioning phase, with the establishment of a donor cell, graft-versus-leukemia effect (GVL). The GVL effect and GVHD are associated with each other and therefore, the goal of GVHD prophylaxis for this study is not so much to prevent all GVHD, but rather to prevent serious and fatal acute GVHD.

Most GVHD-related deaths are either the direct consequence of severe GVHD or from infections associated with intense immunosuppression, a consequence of the standard treatments for acute GVHD, which almost always include high-dose steroids. A more effective prophylaxis therapy that allows for the GVL effect to develop, while limiting the exposure to high-dose steroids may reduce transplant mortality and morbidity. We also will study how key chemical and cellular factors relate to clinical outcome.

Being tested
stem cell transplant, tacrolimus (standard GVHD prophylaxis), mycophenolate (standard GVHD prophylaxis), etanercept, methoxsalen
Keywords
GVHD
Medical subject headings
Graft vs Host Disease

What participants receive

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

  • stem cell transplantProcedure or surgery

    reduced intensity, matched unrelated donor stem cell transplant

  • tacrolimus (standard GVHD prophylaxis)Drug

    Tacrolimus(or cyclosporine when necessary)

    Tacrolimus will begin on day -3, IV or oral.

    Target trough level for tacrolimus is 8-12 ng/ml.

    In the absence of GVHD, tacrolimus tapering will begin on day +56 post transplant

  • mycophenolate (standard GVHD prophylaxis)Drug

    Mycophenolate will begin on day 0 at 10 mg/kg/dose (up to 1 gram per dose) every 8 hours orally or intravenously and will continue until day 28.

  • etanerceptDrug

    Also called Enbrel

    Etanercept will be given at a dose 0.4 mg/kg (actual weight) up to a maximum dose of 25 mg, subcutaneously, twice weekly from day 0 to day 56 (16 doses)

  • methoxsalenDrug

    Also called UVADEX

    Methoxsalen (UVADEX) treatments by Extracorporeal photopheresis (ECP) will be started day +28 post transplant and given weekly.

    On day +70 post transplant ECP frequency will be given every other week.

    On day +100 post transplant ECP will be given monthly until day +180 and stopped.

Study groups in NCT00639717
Study groupRoleWhat they receive
Etanercept and ECPExperimentalEtanercept and ECP (Extracorporeal Photopheresis) in addition to standard GVHD prevention: Etanercept will be given twice weekly by subcutaneous injection starting on the day of HSCT (Hematopoietic stem cell transplantation) conditioning until 8 weeks post transplant. ECP treatments will begin at once weekly starting at 4 weeks post transplant and continue at less frequent intervals until 6 months post transplant. GVHD prophylaxis will consist of a standard two drug regimen: mycophenolate for 4 weeks and tacrolimus (titrated to a therapeutic level) for 8 weeks, then weaned over 4 months with discontinuation by 6 months post-transplant.
Receives: Procedure: stem cell transplant; Drug: tacrolimus (standard GVHD prophylaxis); Drug: mycophenolate (standard GVHD prophylaxis); Drug: etanercept; Drug: methoxsalen

What is being measured

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

  1. Percentage of Patients Alive at 6 Months

    Overall survival at 6 months

    Measured: 6 months

  2. Percentage of Patients Who Experienced Relapse by 6 Months

    Relapse rate at 6 months. Relapse is defined as recurrence of disease.

    Measured: 6 months

Secondary outcomes (3)

  1. The Percentage of Patients That Experienced Graft Versus Host Disease

    Incidence of acute GVHD grades 2-4 and chronic GVHD in this study population

    Measured: 6 Months

  2. Measured Level of Circulating Plasma Markers After Transplant

    Measured: 100 days

  3. Regulatory T Cell Numbers Post-transplant

    Measured: 180 days

Timeline

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

  1. First posted20 Mar 2008 (estimated)
  2. Study startMar 2009
  3. Primary completionJan 2012
  4. Study completionApr 2016

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00639717
Sponsor's protocol ID
umcc 2008.003
Status last verified
Jul 2017
First submitted
11 Mar 2008
Last updated
1 Aug 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing stem cell transplant, tacrolimus (standard GVHD prophylaxis) and mycophenolate (standard GVHD prophylaxis) in people with Graft Versus Host Disease, run by University of Michigan Rogel Cancer Center 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 12 inclusion and 8 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: finished, as of the sponsor's last update on 1 Aug 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Alive at 6 Months (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00639717.

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 1 Aug 2017.

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