NGAM-12 "PRO-SID" Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with CLL
Condition: Chronic lymphocytic leukemia (CLL) and secondary hypogammaglobulinemia
Sponsor: Octapharma
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)
Study Treatment
Randomization to Standard of Care treatment plus regular infusions of Panzyga or Standard of Care treatment plus regular infusions of placebo (0.9% w/v sodium chloride)
Eligibility/Info
-Treatment-naïve or relapsed/refractory CLL patients undergoing CLL antineoplastic treatment. Diagnosis of B-cell CLL established according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and documented within medical records.
-Hypogammaglobulinemia (IgG levels <5 g/L) as confirmed by the study lab
-Exclusion: IgG treatment within 3 months prior to Screening
Contact
For more information you may contact the Research Department through the NYCBS HALO Messaging Center or call directly: 631-675-5075.
