Clinical trial · Interventional
Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig
A Prospective Case Series of Subcutaneous Immunoglobulin for Prophylaxis of Infections in Patients With Chronic Lymphocytic Leukemia With Impaired Humoral Immunity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with chronic lymphocytic leukemia (CLL) are at increased risk of infections as compared to age matched controls, with infections being a major cause of morbidity and mortality. Previous studies have shown that patients with CLL have both hypogammaglobinemia and impaired humoral immunity as defined by vaccine responses to both polysaccharide and peptide antigens. Attempts at decreasing infections in CLL have included therapy with prophylactic antibiotics and intravenous immunoglobulin. In general clinical practice and in previous studies, patients have started IV immunoglobulin replacement therapy if they have a history of serious infection or hypogammaglobinemia (defined as Immunoglobulin G below 500-600 g/dL), but vaccine responses have not been evaluated. This study will identify CLL patients with humoral immunodeficiency by checking both Ig levels and vaccines responses. In patients with impaired humoral immunity, the investigators will use subcutaneous immunoglobulin replacement to show this intervention will increase Ig levels, protective antibody titers, and be well tolerated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Secondary Immune Deficiency Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hizentra | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ig replacement
- description
- Subjects will receive Hizentra 0.4 mg/kg subq once weekly.
- interventionNames
- Drug: Hizentra
Primary outcomes (2)
- measure
- Identify patients with CLL with humoral immunodeficiency despite serum IgG > 500 mg/dL.
- timeFrame
- 10 months
- description
- Incidence of humoral immunodeficiency
- measure
- Number of patients who increase IgG to above 700 mg/dL
- timeFrame
- 10 months
- description
- Effectiveness of Hizentra to change IgG levels
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of chronic lymphocytic leukemia * Medically stable, with expected survival of \> 1 year * Able to understand and willingness to sign a written informed consent * Able to comply with study procedures Exclusion Criteria: * Previously diagnosed primary immunodeficiency * Additional immunosuppressive states as assessed by the primary or co investigators * Ongoing therapy with Ig replacement * Serum IgG \< 500 mg/dL
References
Publications (19)
- BACKGROUNDTwomey JJ. Infections complicating multiple myeloma and chronic lymphocytic leukemia. Arch Intern Med. 1973 Oct;132(4):562-5. No abstract available. PMID 4542660
- BACKGROUNDOscier D, Dearden C, Eren E, Fegan C, Follows G, Hillmen P, Illidge T, Matutes E, Milligan DW, Pettitt A, Schuh A, Wimperis J; British Committee for Standards in Haematology. Guidelines on the diagnosis, investigation and management of chronic lymphocytic leukaemia. Br J Haematol. 2012 Dec;159(5):541-64. doi: 10.1111/bjh.12067. Epub 2012 Oct 11. No abstract available. PMID 23057493
- BACKGROUNDLachance S, Christofides AL, Lee JK, Sehn LH, Ritchie BC, Shustik C, Stewart DA, Toze CL, Haddad E, Vinh DC. A Canadian perspective on the use of immunoglobulin therapy to reduce infectious complications in chronic lymphocytic leukemia. Curr Oncol. 2016 Feb;23(1):42-51. doi: 10.3747/co.23.2810. Epub 2016 Feb 18. PMID 26966403
- BACKGROUNDChapel H, Dicato M, Gamm H, Brennan V, Ries F, Bunch C, Lee M. Immunoglobulin replacement in patients with chronic lymphocytic leukaemia: a comparison of two dose regimes. Br J Haematol. 1994 Sep;88(1):209-12. doi: 10.1111/j.1365-2141.1994.tb05002.x. PMID 7803248
- BACKGROUNDDicato M, Chapel H, Gamm H, Lee M, Ries F, Marichal S, Wirth C, Griffith H, Brennan V. Use of intravenous immunoglobulin in chronic lymphocytic leukemia. A brief review. Cancer. 1991 Sep 15;68(6 Suppl):1437-9. doi: 10.1002/1097-0142(19910915)68:6+3.0.co;2-h. PMID 1878842
- BACKGROUNDMolica S, Musto P, Chiurazzi F, Specchia G, Brugiatelli M, Cicoira L, Levato D, Nobile F, Carotenuto M, Liso V, Rotoli B. Prophylaxis against infections with low-dose intravenous immunoglobulins (IVIG) in chronic lymphocytic leukemia. Results of a crossover study. Haematologica. 1996 Mar-Apr;81(2):121-6. PMID 8641639
- BACKGROUNDRaanani P, Gafter-Gvili A, Paul M, Ben-Bassat I, Leibovici L, Shpilberg O. Immunoglobulin prophylaxis in hematological malignancies and hematopoietic stem cell transplantation. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD006501. doi: 10.1002/14651858.CD006501.pub2.