Phase II study of first line treatment of Chronic Graft versus Host Disease with Arsenic Trioxide - GvHD-ATO

Medsenic0 sites24 target enrollmentNovember 22, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: First line treatment of Chronic Graft versus Host Disease in patients having received a first allogeneic stem cell transplantation for a hematological disease
Sponsor: Medsenic
Enrollment: 24
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

November 22, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Adult patients (\=18 years) who have received a first allogeneic stem cell transplantation for a hematological disease (any source of hematopoietic stem cells is authorized; any category of conditioning regimen prior to allo\-SCT is authorized; any type of stem cell donors is authorized)
•2\. Confirmed diagnosis of a first episode of chronic GvHD requiring systemic immunosuppressive therapy (any prior GvHD prophylaxis previously used is accepted). Chronic GvHD diagnosis is defined according to the NIH Working Group Consensus. Chronic GvHD diagnosis will be based on the evaluation of the severity of the different clinical manifestations including:
•a/ Performance status evaluation
•b/ Cutaneous evaluation measured by the percentage of extension or the presence of sclerotic features. If relevant, confirmation with a biopsy should be performed whenever possible
•c/ Oral symptoms
•d/ Ocular symptoms
•e/ Gastro\-intestinal symptoms
•f/ Evaluation of liver involvement (total bilirubin, transaminases and alkaline phosphatases)
•g/ Pulmonary function evaluation
•h/ Evaluation of the musculoskeletal manifestations, especially the amplitude of the relevant articulations

•1\. Patient developing acute GvHD (whether early or late onset” form)
•2\. Patients developing overlap GvHD as defined by the 2014 NIH Working Group Consensus (presence of one or more acute GvHD manifestations in a patient with a diagnosis of chronic GvHD)
•3\. A mild” form of chronic GvHD not requiring systemic immunosuppressive therapy
•4\. A moderate” form of chronic GvHD limited to one organ site not requiring systemic immunosuppressive therapy
•5\. Patient receiving mycophenolate mofetil
•6\. GvHD occurring following donor lymphocytes infusion (DLI)
•7\. Not the first episode of chronic GvHD needing systemic immunosuppressive therapy
•8\. Second allogeneic stem cell transplant
•9\. Significant arrhythmias, electrocardiogram (EKG) abnormalities:
•a/ Congenital QT syndromes