A Phase III Study of Panzyga to Prevent Infection in People with Chronic Lymphocytic Leukemia

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Full Title

Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia (“PRO-SID” study) (WIRB)

Purpose

The purpose of this study is to see if the medication Panzyga (immunoglobulin G) is effective for preventing infection in people with chronic lymphocytic leukemia (CLL) who have “hypogammaglobulinemia” (a type of depressed immunity). Patients in this study will be randomly assigned to receive Panzyga or a placebo (inactive treatment). The treatments are given intravenously (by vein).

Eligibility

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

  • Patients must be receiving treatment for B-cell CLL and have hypogammaglobulinemia.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Anthony Mato at 646-608-3748.

Protocol

21-032

Phase

III

Investigator

Co-Investigators