Study of BEGEDINA® vs "Conventional Treatment" for Treating Steroid-Resistant Acute GvHD (NCT02411084) | Clinical Trial Compass
TerminatedPhase 3
Study of BEGEDINA® vs "Conventional Treatment" for Treating Steroid-Resistant Acute GvHD
Stopped: Insufficient rate of accrual
United States36 participantsStarted 2016-02
Plain-language summary
The objectives of this study are to determine the efficacy and safety of BEGEDINA® in subjects with steroid resistant acute graft versus host disease (GvHD). GvHD is a rare and complex immunological disease occurring in some recipients of allogeneic hematopoietic stem cell transplants (HSCTs) and affecting principally the skin, liver and gastrointestinal (GI) tissues. The disease is life threatening and may be acute or chronic and the first choice treatment for patients with acute GvHD (Grade II or higher) is the immunosuppressive corticosteroid hormone methylprednisolone. However, some GvHD patients may be resistant to this treatment leading to disease progression and a high rate of morbidity and mortality, primarily from infections and/or multi-organ failure. There are currently no other satisfactory therapies. BEGEDINA® is a therapeutic monoclonal antibody that recognises and binds to CD26 on CD4+ T lymphocytes. BEGEDINA® reduces the activity of CD26 in these cells and inhibits the immune response leading to improvement in patients that have shown steroid resistance. This study is therefore aimed at demonstrating that BEGEDINA® is a safe and effective treatment for steroid-resistant GvHD patients where no other such treatments are currently available.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age ≥18 and ≤65 years of age.
✓. Recipient of an allogeneic hematopoietic stem cell transplantation (HSCT). Note: Subjects with GvHD following donor lymphocyte infusion post-HSCT are also eligible
✓. Steroid-resistant acute GvHD, Grade II-IV, defined as: progressive disease (deterioration of at least 1 stage in 1 organ) after 3 days of primary treatment with methylprednisolone 2 mg/kg, or equivalent. or lack of at least a partial response (PR) after 7 days of primary treatment with methylprednisolone 2 mg/kg or equivalent. or lack of a complete response (CR) after 14 days of primary treatment with methylprednisolone 2 mg/kg or equivalent. Note: Subjects who may have received an increase in their steroid dose treatment prior to randomization will be eligible for enrollment. An increase in steroid dose will not be considered as second-line therapy.
✓. Evidence of previous myeloid engraftment (absolute neutrophil count ≥0.5 x 10\^9/L).
✓. Karnofsky Performance Status Scale ≥50%.
✓. Adequate renal function as defined by serum creatinine ≤2 × upper limit of normal or calculated creatinine clearance (CrCl) of ≥30 mL/min using the Cockroft-Gault equation: Calculated CrCl= (\[140-age in years\] x \[ideal body mass {IBM} in kg\])/72 x (serum creatinine value in mg/dL), where IBM = IBM (kg) = (\[height in cm- 154\] × 0.9) + (50 if male, 45.5 if female).
✓
What they're measuring
1
Number of Participants With Overall Response at 28 Days
. Subject must be willing and able to comply with study requirements, remain at the clinic, and return to the clinic for the follow-up evaluation, as specified in this protocol during the study period.
✓. Able and willing to provide signed informed consent.
Exclusion criteria
✕. Prior second-line systemic treatment for GvHD.
✕. Received agents other than steroids for primary treatment of acute GvHD.
✕. Stage 1-2 skin acute GvHD alone (with no other organ involvement).
✕. Acute steroid resistant GvHD beyond 28 days from first-line therapy (primary treatment).
✕. Evidence of severe hepatic veno-occlusive disease or sinusoidal obstruction.