A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
Recruiting · Phase 3 · NCT05645107
Conditions: Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia, Multiple Myleoma, Non-Hodgkin Lymphoma
At a glance
- Research payments reported, 2025
- $1.1M
- U.S. investigators named
- 5
- Sites paid
- 5
- Planned or actual enrollment
- 386
About the trial
- Sponsor
- Grifols Therapeutics LLC
- Tested
- Xembify (drug), Placebo (drug)
- Dates
- Started 2022-12-26; completion 2029-08
- Results posted
- Not yet
The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.
From ClinicalTrials.gov, last updated 2026-09-30. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Grifols Therapeutics LLC reported $1.1M in research payments for this study in 2025 (100 payments).
Products named: Xembify, Albutein
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Debra Weinstein, MD Internal Medicine · Boynton Beach, FL
- Shaalan Beg, MD Medical Oncology · Boise, ID
- Luke Pittman, MD Allergy & Immunology · Bethesda, MD
- Darla K. Liles, MD Hematology & Oncology · Greenville, NC
- Nashat Gabrail, M.D. Specialist · Canton, OH
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Science 37, Inc $448,448
- Gabrail Cancer Center Research LLC $406,483
- Walter Reed National Military Medical Center $261,710
- Henry M Jackson Foundation for The Advancement of Military Medicine $20,573
- East Carolina University $1,040
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.