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Xembify versus placebo plus standard medical treatment for infection prevention in adults with hypogammaglobulinemia associated with B-cell hematologic malignancies
2022-502193-16-00Phase 3Authorised
- Sponsor
- Grifols
- Start
- Nov 2023
- Countries
- 7
01
Overview
Phase 3, randomised, double-blind trial in hypogammaglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), multiple myeloma (MM) and 1 more comparing Xembify plus standard medical treatment with Placebo plus standard medical treatment (2 arms). Primary endpoint: Annual rate of major bacterial infections. Planned start Nov 2023; status: authorised.
02
Drugs
polyvalent human immunoglobulin
03
Conditions
hypogammaglobulinemiachronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)multiple myeloma (MM)non-Hodgkin lymphoma (NHL)
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