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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Graft Versus Host Disease
and you are
between 18 and 70
years old
This is a medium phase trial determining
the safety and dosage of the new treatment, as well as its efficacy.
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The purpose

In this study the investigators are proposing to treat patients with steroid-refractory Graft-versus-host Disease (GVHD) in a manner designed to promote CD4+CD25+FoxP3+ Tregs. The profound immune suppression which follows the most common salvage treatment for GVHD have unfortunately lead to very poor outcomes because of high infection rates. A more targeted approach based on the promotion and stabilization of Tregs is hoped to allow GVHD control without the profound immunosuppression usually seen. High-dose cyclophosphamide and sirolimus have been successfully used for the prevention of GVHD and have shown to enhance the Tregs subpopulation. The addition of low dose IL-2 and a demethylating agent such as azacitidine will also be studied in an attempt to promote and stabilize the FoxP3 expression of Tregs.

Provided treatments

  • Drug: Cyclophospahmide and Sirolimus
  • Drug: Low dose IL-2, Cyclophosphamide and Sirolimus
  • Drug: Low dose IL-2, low dose Vidaza, cyclophosphamide & Sirolimus

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01453140. The sponsor of the trial is Hackensack Meridian Health and it is looking for 3 volunteers for the current phase.
Official trial title:
Phase I- II Study of in Vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus With or Without Vidaza (Azacitidine) for the Treatment of Steroid-refractory Acute Graft-versus-host Disease