Octapharma: NGAM-12 Ph3 Panzyga CLL patients (Chronic Lymphocytic Leukemia) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called Panzyga (the study drug) is effective at preventing infections in people who have chronic lymphocytic leukemia (CLL).

What is the Condition Being Studied?

Chronic Lymphocytic Leukemia (CLL) and Hypogammaglobulinemia

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with CLL and Hypogammaglobulinemia
- Do not have HIV or Hepatitis B/C
- Are not pregnant

For more information about who can join this study, please contact the study team at 919-681-6580.

Age Group
Adults

What is Involved?

This study has 3 parts: a screening period, a study drug period, and a follow-up period.

If you choose to join this study, you will begin a screening period to see if you are eligible. During the screening period, you will:
- Have a physical exam
- Answer questionnaires
- Have blood draws
- Give urine samples
- Have heart scans (ECG and echocardiogram)
- Have a chest x-ray if it has been more than 3 months since your last x-ray or CT scan

If you are eligible to continue on to the study drug period, you will:
- Be randomly assigned (like a coin flip) to 1 of 2 groups
-- One group will receive the study drug
-- The other group will receive a placebo (inactive substance)
- Receive the study drug or placebo by infusion (IV) every 4 weeks
- Have blood draws
- Have physical exams

You will receive up to 14 doses of the study drug during the study. Each visit for an infusion will last about 3 hours.

The follow-up period begins after your last dose of the study or placebo. You will return to our clinic for one more visit. At this visit, you will:
- Have a physical exam
- Answer questionnaires
- Have blood draws
- Give a urine sample

Study Details

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)
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB: PRO00104764
NCT: NCT04502030
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698