Prospective, phase II/III, randomized clinical study to compare BEGEDINA® versus conventional treatment” for treating steroid resistant acute graft-versus host disease

ADIENNE SA0 sites36 target enrollmentSeptember 11, 2015

Overview

No summary available.

Registry

who.int

Start Date

September 11, 2015

End Date

July 31, 2017

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. Age \=18 and \=65 years of age.
•2\. Recipient of an allogeneic (HSCT).Note: Subjects with steroid resistant GvHD following donor lymphocyte infusion post HSCT are also eligible
•3\. 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.
•\- lack of at least a PR after 7 days of primary treatment with methylprednisolone 2 mg/kg or equivalent.
•\- lack of a 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.
•4\. Evidence of previous myeloid engraftment (absolute neutrophil count \=0\.5 x 109/L) .
•5\. Karnofsky Performance Status Scale \=50%.
•6\. Adequate renal function as defined by serum creatinine \=2 × upper limit of normal (ULN) 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).

•1\. Prior second\-line systemic treatment for GvHD.
•2\. Received agents other than steroids for primary treatment of acute GvHD.
•3\.Stage 1\-2 skin acute GvHD alone (with no other organ involvement).
•4\.Acute Steroid resistant GvHD beyond 28 days from first\-line therapy (primary treatment).
•5\. Evidence of severe hepatic veno\-occlusive disease or sinusoidal obstruction.
•6\. Evidence of encephalopathy.
•7\. Life expectancy \<3 weeks.
•8\. Presence of chronic GvHD (Dignan et al., 2012\)
•9\. Second or subsequent allogeneic transplant.
•10\. Received a solid organ transplant (with the exception of a corneal transplant \>3 months prior to screening).