Panzyga for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+75 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Octapharma

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing Panzyga, a medication made from human blood plasma, to see if it can help prevent infections in patients with Chronic Lymphocytic Leukemia. These patients have weakened immune systems and need extra antibodies to fight off infections. Panzyga is used to prevent serious bacterial infections.

Eligibility Criteria

This trial is for adults over 18 with Chronic Lymphocytic Leukemia (CLL) who have low IgG levels and are either untreated or relapsed. They must not have had major infections recently, severe liver or kidney disease, weigh over 140 kg, or be HIV positive. Women of childbearing age must agree to use contraception.

Inclusion Criteria

Hypogammaglobulinemia (IgG levels <5 g/L) as confirmed by the Central Laboratory.

I am 18 years old or older.

I have CLL and am starting or retrying treatment.

+1 more

Exclusion Criteria

I have severe liver disease with symptoms like fluid in the abdomen or confusion.

I am not on any immunosuppressive drugs or forbidden medications for the study.

I have a condition or cancer other than CLL that may shorten my life to under two years.

+17 more

Participant Groups

The study tests Panzyga's effectiveness in preventing infections in CLL patients compared to a placebo. It's double-blind meaning neither the participants nor the researchers know who gets what treatment until after the results are analyzed.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PanzygaExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Panzyga is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Panzyga for: