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WithdrawnNCT02425813Updated Aug 2, 2018

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

A Phase 2 interventional study of Budesonide and Methylprednisolone Sodium Succinate in Acute Graft Versus Host Disease and Intestinal Graft Versus Host Disease, sponsored by Wake Forest University Health Sciences. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-02.

Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Slow Accrual
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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:

I. 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:

I. 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.

02

Conditions studied

  • Acute Graft Versus Host Disease
  • Intestinal Graft Versus Host Disease

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03

In context

Graft vs Host Disease

806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.

Browse Graft vs Host Disease studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment (methylprednisolone sodium succinate, budesonide)

    STUDY 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.

    Drug: Budesonide · Drug: Methylprednisolone Sodium Succinate

Interventions

  • DrugBudesonide

    Given PO

    Also known as: Budecort, Butacort, Eltair, Nasocort, Preferid, Pulmicort, Pulmicort Turbuhaler, Rhinocort

  • DrugMethylprednisolone Sodium Succinate

    Given IA and IV

    Also known as: A-MethaPred, Asmacortone, Cryosolona, Medrate, Metypred, Prednilem, Solu Moderin, Solu-Medrol, Solu-Medrone

06

What researchers measure

Primary outcomes

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

    Time frame: Day 56

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

    Time frame: By day 180

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

    Time frame: By day 360

  4. Proportions of response among surviving patients

    Time frame: Day 14

  5. Proportions of progression among surviving patients

    Time frame: 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.

    Time frame: Day 56

  7. Proportions of response among surviving patients

    Time frame: Day 28

  8. Proportions of progression among surviving patients

    Time frame: Day 28

Secondary outcomes

  1. Daily and cumulative GC dose

    Descriptive measures will be provided at each time point specified.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to day 56

  6. Incidence of chronic GvHD

    Descriptive measures will be provided at each time point specified.

    Time frame: By day 180

  7. Incidence of chronic GvHD

    Descriptive measures will be provided at each time point specified.

    Time frame: 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.

    Time frame: Up to day 360

  9. Incidence of opportunistic infections

    Descriptive measures will be provided at each time point specified.

    Time frame: Day 180

  10. Non-relapse mortality (NRM)

    Descriptive measures will be provided at each time point specified.

    Time frame: Day 180

  11. NRM

    Descriptive measures will be provided at each time point specified.

    Time frame: Day 360

  12. Overall survival

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

    Time frame: Day 180

  13. Overall survival

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

    Time frame: Day 360

07

Study locations

1 site
  • Comprehensive Cancer Center of Wake Forest University
    Winston-Salem, North Carolina 27157, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02425813
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 24, 2015
Start date
Oct 2015
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Aug 2, 2018

Study contacts

Gordon Phillips
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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