A Phase III Study of Viralym-M (ALVR105) to Treat Virus-Associated Bladder Inflammation after Receiving a Donated Stem Cell Transplant

Share
Print

Full Title

Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR-105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant (WIRB)

Purpose

Hemorrhagic cystitis is an inflammation of the bladder that causes bladder pain and blood in the urine. It may occur as a result of a viral infection after a patient has received an allogeneic stem cell transplant (from another person). It develops from viruses that are normally harmless in the patient’s body, but which can become active due to reduced immunity after the transplant.

In this study, researchers are comparing the investigational treatment Viralym-M (ALVR105) with a placebo in patients with virus-associated hemorrhagic cystitis after an allogeneic stem cell transplant. Viralym-M contains T cells (white blood cells) from healthy human donors that could help defend the body against specific viruses. Patients will be randomly assigned to receive Viralym-M or a placebo intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have hemorrhagic cystitis following allogeneic stem cell transplantation that was performed at least 21 days and no more than 1 year before entering the study.
  • This study is for patients age 1 year and older.

For more information about this study and to inquire about eligibility, please contact Dr. Susan Prockop at 212-639-3267.

Protocol

21-107

Phase

III

Investigator

Prockop, Susan, MD

Co-Investigators