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Acute Graft Versus Host DiseasePhase 2NCT02425813

Methylprednisolone Sodium Succinate in Treating Patients With Acute Graft-versus-Host Disease of the Gastrointestinal Tract

A Phase 2 study testing Budesonide and Methylprednisolone Sodium Succinate in people with Acute Graft Versus Host Disease and Intestinal Graft Versus Host Disease, run by Wake Forest University Health Sciences at 1 site 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Withdrawn

Withdrawn.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 methylprednisolone sodium succinate works in treating patients with graft-versus-host disease (GVHD) of the gastrointestinal tract that has begun within 100 days of transplant (acute GVHD). Corticosteroids are a type of drug that reduces inflammation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Budesonide and Methylprednisolone Sodium Succinate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2015to Jul 2016
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

  • Diagnosis of acute GvHD of the GIT (any site except isolated "upper" GIT disease); other sites may be involved as well; their presence will not influence eligibility
  • Biopsies are strongly recommended and should be obtained, ideally, by full endoscopy including esophagogastroduodenoscopy (EGD) and flexible sigmoidoscopy or colonoscopy
  • However, and with an appropriate clinical presentation, it is desirable -- but not necessary -- to have pathology confirmation
  • If other diagnoses are excluded, it is not necessary to biopsy all potentially involved sites in the GIT to initiate therapy
  • It is possible that other diagnoses may be present as well, and this should not exclude eligibility so long as they are distinct (this statement is generic, but applies especially to various types of infective colitis; that said, on-going anti-infective therapy must be on-going)
  • Any diagnosis, donor or source of hematopoietic stem cells (HSC) is allowed, including donor leukocyte infusions (DLI)
Show all 15Show fewer
  • Prior or on-going therapy:
  • De novo disease with no previous systemic (topical allowed) therapy for acute GvHD --except for a maximum (and ideally much less) of 72 hours of prior glucocorticoid (GC) therapy, > 0.5 mg/kg/day of MePDSL or equivalent after the onset of acute GvHD
  • An exception to the above exists for patients with prior acute GvHD (of any site) who received GC therapy, experienced a complete response (CR), were tapered off GC and recurred >= 15 days later; such are eligible after review by the principal investigator (PI) or his designee
  • The use of on-going acute GvHD prophylaxis will be continued
  • The use of any other IST is allowed if acute GvHD of the GIT develops while the patient is off all IST; IST may be started at the discretion of the attending physician after discussion with the PI of this study
  • Treatment with oral budesonide is to be started or continued at full dose
  • Please consult with the study PI regarding any questions or concerns of study eligibility
  • No specific organ function parameters are required; however, significant abnormalities should be discussed with the study PI
  • Ability to understand and the willingness to sign the Institutional Review Board (IRB)-approved informed consent document

Who cannot join

  • Significant risk factors for IASA therapy including, but not limited to: major uncorrectable coagulopathy, bowel perforation, ongoing bacteremia, mesenteric insufficiency, etc; in these or any questionable cases, discussion with the PI is recommended
  • Patients may not be receiving any other drugs for the treatment of GvHD or investigational agents, except for a maximum of 72 hours of prior GC therapy, as above
  • Uncontrolled, severe infective processes
  • Patients with relapsed or persistent malignancy requiring immunosuppressive withdrawal or modulation (an example of this may be a patient who relapsed and was being treatment with DLI and then developed GvHD)
  • Pregnant women are excluded from this study; breastfeeding should be discontinued

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Comprehensive Cancer Center of Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Intra-Arterial Steroid Administration of De Novo Acute Graft-vs-Host Disease of the Gastrointestinal Tract: A Phase II Study

This phase II trial studies how well methylprednisolone sodium succinate works in treating patients with graft-versus-host disease (GVHD) of the gastrointestinal tract that has begun within 100 days of transplant (acute GVHD). Corticosteroids are a type of drug that reduces inflammation. Giving corticosteroid drugs, such as methylprednisolone sodium succinate, directly into the arteries of the gastrointestinal tract may help treat inflammation caused by GVHD. Giving methylprednisolone sodium succinate in addition to standard treatments may be more effective in treating GVHD.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the efficacy of intra-arterial steroid administration (IASA) with methylprednisolone sodium succinate (MePDSL) in this dose-schedule for treatment of de novo acute moderate-to-severe GvHD of the gastrointestinal tract (GIT).

SECONDARY OBJECTIVES:

  1. To assess the safety of IASA MePDSL in this dose-schedule for treatment of de novo acute moderate-to-severe acute GvHD of the GIT.

II. To assess the feasibility of IASA MePDSL in this dose-schedule for treatment of de novo acute moderate-to-severe acute GvHD of the GIT.

OUTLINE:

STUDY AGENT: Patients receive methylprednisolone sodium succinate intra-arterially (IA) once daily (QD) on days 1-3.

CONVENTIONAL THERAPY: Patients also receive conventional therapy comprising methylprednisolone sodium succinate intravenously (IV) every 12 hours on for 7-14 days beginning on day 1 and budesonide PO on days 1-56. Patients with response by day 7-14 may begin taper and receive methylprednisolone orally (PO) on days 28-56. Treatment continues in the absence of disease progression or unacceptable toxicity.

IMMUNOSUPPRESSIVE THERAPY (IST): Patients receive conventional IST or continue their previous prophylactic regimen beginning on day 1 to 56 (or beyond) at the discretion of the treating physician.

After completion of study treatment, patients are followed up for 360 days.

Being tested
Budesonide, Methylprednisolone Sodium Succinate

What participants receive

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

  • BudesonideDrug

    Also called Budecort, Butacort, Eltair, Nasocort

    Given PO

  • Methylprednisolone Sodium SuccinateDrug

    Also called A-MethaPred, Asmacortone, Cryosolona, Medrate

    Given IA and IV

Study groups in NCT02425813
Study groupRoleWhat they receive
Treatment (methylprednisolone sodium succinate, budesonide)ExperimentalSTUDY AGENT: Patients receive methylprednisolone sodium succinate IA QD on days 1-3. CONVENTIONAL THERAPY: Patients also receive conventional therapy comprising methylprednisolone sodium succinate IV every 12 hours on for 7-14 days beginning on day 1 and budesonide PO on days 1-56. Patients with response by day 7-14 may begin taper and receive methylprednisolone PO on days 28-56. Treatment continues in the absence of disease progression or unacceptable toxicity. IST: Patients receive conventional IST or continue their previous prophylactic regimen beginning on day 1 to 56 (or beyond) at the discretion of the treating physician.
Receives: Drug: Budesonide; Drug: Methylprednisolone Sodium Succinate

What is being measured

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

  1. Incidence of discontinuation of systemic GCs without acute GvHD flare and without disease progression/recurrence

    Measured: Day 56

  2. Incidence of discontinuation of systemic GCs without acute GvHD flare and without disease progression/recurrence

    Measured: By day 180

  3. Incidence of discontinuation of systemic GCs without acute GvHD flare and without disease progression/recurrence

    Measured: By day 360

  4. Proportions of response among surviving patients

    Measured: Day 14

  5. Proportions of progression among surviving patients

    Measured: Day 14

  6. Rate of acute (and/or chronic) GvHD-free survival

    Simon's two-stage design will be used. The null hypothesis that the true CR rate is 30% will be tested against a one-sided alternative and presented with a 95% confidence interval.

    Measured: Day 56

  7. Proportions of response among surviving patients

    Measured: Day 28

  8. Proportions of progression among surviving patients

    Measured: Day 28

Secondary outcomes (13)

  1. Daily and cumulative GC dose

    Descriptive measures will be provided at each time point specified.

    Measured: Day 28

  2. Feasibility

    Feasibility will be defined as less than three IASA sessions for any reason and obvious procedure-related problems in >= 10% of patients. Descriptive measures will be provided at each time point specified.

    Measured: Up to day 360

  3. GvHD-free survival

    Descriptive measures will be provided at each time point specified. Survival estimates will be calculated using Kaplan-Meier estimation.

    Measured: Day 180

  4. GvHD-free survival

    Descriptive measures will be provided at each time point specified. Survival estimates will be calculated using Kaplan-Meier estimation.

    Measured: Day 360

  5. Incidence of acute GvHD "flare" after CR/PR requiring modification and/or additional agents (and/or 2.5 mg/kg/day of prednisone [or methylprednisolone equivalent of 2 mg/kg/day]) for systemic therapy

    Descriptive measures will be provided at each time point specified.

    Measured: Up to day 56

  6. Incidence of chronic GvHD

    Descriptive measures will be provided at each time point specified.

    Measured: By day 180

  7. Incidence of chronic GvHD

    Descriptive measures will be provided at each time point specified.

    Measured: By day 360

  8. Incidence of National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 toxicities

    Frequencies of toxicities grade 2 or higher will be totaled at the conclusion of the study.

    Measured: Up to day 360

  9. Incidence of opportunistic infections

    Descriptive measures will be provided at each time point specified.

    Measured: Day 180

  10. Non-relapse mortality (NRM)

    Descriptive measures will be provided at each time point specified.

    Measured: Day 180

  11. NRM

    Descriptive measures will be provided at each time point specified.

    Measured: Day 360

  12. Overall survival

    Descriptive measures will be provided at each time point specified. Survival estimates will be calculated using Kaplan-Meier estimation.

    Measured: Day 180

  13. Overall survival

    Descriptive measures will be provided at each time point specified. Survival estimates will be calculated using Kaplan-Meier estimation.

    Measured: Day 360

Timeline

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

  1. First posted24 Apr 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Why it stopped: Slow Accrual

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02425813
Sponsor's protocol ID
IRB00032434
Other IDs
NCI-2015-00548, CCCWFU 98115, P30CA012197
Status last verified
Jul 2018
First submitted
15 Apr 2015
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Budesonide and Methylprednisolone Sodium Succinate in people with Acute Graft Versus Host Disease and Intestinal Graft Versus Host Disease, run by Wake Forest University Health Sciences 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 15 inclusion and 5 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 2 Aug 2018. 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?

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?

Incidence of discontinuation of systemic GCs without acute GvHD flare and without disease progression/recurrence (time frame: Day 56). The study lists 8 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 NCT02425813.

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 2 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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