Randomized Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal GVHD

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with gastrointestinal graft-vs.-host disease are randomized to oral beclomethasone dipropionate (BDP) 8 mg/day or identical placebo tablets for 50 days, along with a 10-day induction course of prednisone. At study day 10, patients whose symptoms of GVHD are under control undergo a rapid prednisone taper over 7 days, while study drug is continued to study day 50. After discontinuation of study drug at study day 50, patients are followed for 30 additional days, to study day 80. The primary endpoint is treatment failure by day 50, that is, a flare of the symptoms of GVHD that requires immunosuppressive therapy. Secondary endpoints are treatment failure by day 80, treatment-emergent adverse events, and survival at transplant day 200. The hypothesis to be tested is that a topically-active corticosteroid (beclomethasone dipropionate, BDP), taken orally, would allow rapid tapering of prednisone while maintaining control of intestinal GVHD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enteron Pharmaceuticals
• Treatments: Beclomethasone; Prednisone

Criteria

Inclusion Criteria:

• Allogeneic hematopoietic cell transplant ≥10 days prior to screening

• Symptoms consistent with Grade II intestinal GVHD

• Diagnosis of GVHD confirmed by biopsy

• Confirmed absence of intestinal infection

• Demonstrated ability to swallow 2 tablets of the size and configuration of study drug

• Anti-candidal prophylaxis of the oropharynx

• If female and of childbearing potential, willing to use contraception

• Ability to read, understand, and sign informed consent

Exclusion Criteria:

• Skin GVHD other than a slowly evolving skin rash that involves ≤50% of body surface

• Liver GVHD with total serum bilirubin >3 mg/dL

• Negative intestinal biopsy for GVHD

• Systemic prescription corticosteroid use within 30 days

• Persistent vomiting of oral intake the precludes ingestion of study drug tablets

• Multiorgan failure

• Infection of the mouth or esophagus with a fungal organism

• Known HIV seropositivity

• Pregnancy or lactation

• Previous use of BDP tablets, capsules, or inhalation products

• Use of any investigational drug, biologic, or device within 30 days

• Inability to comply with study procedures and scheduled study visits