Clinical trial NCT02425813 (phase 2, status: withdrawn)
Conditions: acute graft versus host disease, intestinal graft versus host disease
ICD codes: D89.810, D89.812
Drugs: budesonide, methylprednisolone sodium succinate
SMILES: COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@]12C
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        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:

          -  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