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Graft Versus Host DiseasePhase 2NCT02174263

Tocilizumab for Chronic Graft-versus-Host Disease Treatment

A Phase 2 study testing tocilizumab, laboratory biomarker analysis and quality-of-life assessment in people with Graft Versus Host Disease, run by Fred Hutchinson Cancer Center at 5 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies how well tocilizumab works in treating chronic graft-versus-host disease (GVHD) in patients that have not responded to treatment after at least two prior therapies. Tocilizumab blocks a protein that stimulates the body's immune system. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Graft Versus Host Disease
What is being tested?
tocilizumab, laboratory biomarker analysis and quality-of-life assessment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
5 sitesUnited States
Study dates
Feb 2016to Aug 2019
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has moderate or severe overlap chronic (c)GVHD according to National Institutes of Health (NIH) criteria
  • Active cGVHD despite treatment with at least two immunosuppressive treatments (not including GVHD prophylaxis) in the past year
  • Subject underwent allogeneic stem cell transplantation at least 6 months prior to enrollment
  • Subject has not started any new systemic immunosuppressive therapies within 2 weeks prior to enrollment
  • Female subjects of child bearing potential must have a negative pregnancy test prior to first dose of tocilizumab and must agree to practice effective contraception during the study
  • Subject meets the following medication restriction requirements and agrees to follow medication restrictions during the study; the following concomitant medications are not allowed: cyclophosphamide, abatacept, etanercept, adalimumab infliximab, golimumab, tofacitinib, and alemtuzumab; these medications also cannot have been used for 5 half-lives prior to enrollment
  • Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits

Who cannot join

  • Donor lymphocyte infusion in the preceding 100 days
  • Subject has bronchiolitis obliterans, bronchiolitis obliterans with organizing pneumonia or cryptogenic organizing pneumonia as the sole manifestation of cGVHD
  • Uncontrolled bacterial, viral infection or invasive fungal infection
  • Evidence of malignancy within 6 months of study enrollment; this is defined as clear morphologic, radiologic or molecular evidence of disease; mixed chimerism is allowed at the discretion of the clinician
  • Treatment with any non-Food and Drug Administration (FDA) approved agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of study enrollment
  • Immunization with a live, attenuated vaccine within 4 weeks prior to study enrollment
Show all 18Show fewer
  • History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
  • Tuberculosis requiring treatment within the past 3 years; all patients must have a negative quantiferon test within 4 weeks prior to starting study drug
  • Pregnant or breast-feeding women
  • Patients (both men and women) with reproductive potential not willing to use an effective method of contraception
  • Serum creatinine > 1.6 mg/dL (141 umol/L) in females and > 1.9 mg/dL (168 umol/L) in males; patients with serum creatinine values exceeding these limits are eligible for the study if their estimated glomerular filtration rates (GFR) are > 30 ml/min/1.73 m^2
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times upper limit of normal (ULN)
  • Total bilirubin > upper limit of normal (ULN)
  • Absolute neutrophil count < 1.5 x 10^9/L (1500/mm^3)
  • Known active hepatitis B or C; patients must have a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody within 4 weeks prior to starting study drug
  • Known uncontrolled cytomegalovirus (CMV) polymerase chain reaction (PCR) reactivation per institutional standards; once CMV has been treated and stable per institutional standards, patient may be enrolled; CMV PCR will be tested within two weeks prior to starting study drug
  • History of diverticulitis, Crohn's disease or ulcerative colitis
  • History of demyelinating disorder

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Tocilizumab in Chronic GVHD Refractory to at Least Two Prior Therapies

This phase II trial studies how well tocilizumab works in treating chronic graft-versus-host disease (GVHD) in patients that have not responded to treatment after at least two prior therapies. Tocilizumab blocks a protein that stimulates the body's immune system. By blocking this protein, the investigators may reduce the symptoms of chronic GVHD.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Efficacy will be determined by the proportion of patients with failure free survival (FFS) at 6 months.

SECONDARY OBJECTIVES:

  1. Patients achieving a complete response (CR) or partial response (PR) at 6 months based on clinician judged response.

II. Patients achieving a CR or PR by objective response measures at 6 months.

III. Failure-free survival (FFS) at 1 year.

IV. Change in steroid dose from enrollment to 6 months (mo).

TERTIARY OBJECTIVES:

  1. Biologic studies will be done to determine possible mechanisms of response.

OUTLINE:

Patients receive tocilizumab intravenously (IV) over 1 hour every 2 weeks for 12 weeks (weeks 1, 3, 5, 7, 9, and 11) and then every 4 weeks for 12 weeks (weeks 13, 17, and 21).

After completion of study treatment, patients are followed up at 3 and 6 months.

Being tested
tocilizumab, laboratory biomarker analysis, quality-of-life assessment
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.

  • tocilizumabBiological

    Also called Actemra, immunoglobulin G1, anti-(human interleukin 6 receptor) (human-mouse monoclonal MRA heavy chain), disulfide with human-mouse monoclonal MRA kappa chain dimer, MRA, R-1569

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

  • quality-of-life assessmentOther

    Also called quality of life assessment

    Ancillary studies

Study groups in NCT02174263
Study groupRoleWhat they receive
Supportive care (tocilizumab)ExperimentalPatients receive tocilizumab IV over 1 hour every 2 weeks for 12 weeks (weeks 1, 3, 5, 7, 9, and 11) and then every 4 weeks for 12 weeks (weeks 13, 17, and 21).
Receives: Biological: tocilizumab; Other: laboratory biomarker analysis; Other: quality-of-life assessment

What is being measured

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

  1. FFS

    Measured: At 6 months

Secondary outcomes (3)

  1. Patients achieving CR or PR based on objective measures, as recommended by the NIH Consensus Conference for chronic GVHD

    Measured: At 6 months

  2. Patients achieving a CR or PR based on clinician judged response

    Measured: At 6 months

  3. Relative change in daily prednisone dose

    Prednisone is not a pre-specified intervention; however, some patients may take prednisone while on this study.

    Measured: Baseline to 6 months

Timeline

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

  1. First posted25 Jun 2014 (estimated)
  2. Study startFeb 2016
  3. Primary completionAug 2019 (estimated)

Why it stopped: Study never opened due to lack of funds.

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02174263
Sponsor's protocol ID
9130
Other IDs
NCI-2014-01204, 9130, P30CA015704
Status last verified
May 2016
First submitted
23 Jun 2014
Last updated
6 May 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tocilizumab, laboratory biomarker analysis and quality-of-life assessment in people with Graft Versus Host Disease, run by Fred Hutchinson Cancer Center at 5 sites 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 7 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: withdrawn, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

FFS (time frame: At 6 months). 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 NCT02174263.

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 6 May 2016.

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