Clinical trial · Interventional
Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig
The Use of 20% Subcutaneous Immunoglobulin Replacement Therapy in Patients With B Cell Non Hodgkin's Lymphoma With Humoral Immune Dysfunction After Treatment With Rituximab
NCT03211065CI-TRIAL-00051304completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy (replacement of antibodies, which are infection-fighting proteins) in patients with a type of blood cancer called lymphoma, who have been treated with rituximab (a type of chemotherapy) and have an abnormal immune system putting them at increased risk of infection.
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 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 20% subcutaneous immunoglobulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunoglobulin therapy
- description
- Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.
- interventionNames
- Drug: 20% subcutaneous immunoglobulin
Primary outcomes (1)
- measure
- Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment
- timeFrame
- 1 year
- description
- How many antibiotics are prescribed in one year for any type of infection
Secondary outcomes (1)
- measure
- Quality of life score for participants during the one year enrollment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of B cell non-Hodgkin's lymphoma 2. Medically stable 3. Able to understand and willingness to sign a written informed consent 4. Able to comply with study procedures Exclusion Criteria: 1. Previously diagnosed primary immunodeficiency 2. Additional immunosuppressive states 3. Ongoing therapy with Ig replacement
References
Publications (13)
- BACKGROUNDKaplan B, Kopyltsova Y, Khokhar A, Lam F, Bonagura V. Rituximab and immune deficiency: case series and review of the literature. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):594-600. doi: 10.1016/j.jaip.2014.06.003. Epub 2014 Aug 7. PMID 25213054
- BACKGROUNDDavis TA, White CA, Grillo-Lopez AJ, Velasquez WS, Link B, Maloney DG, Dillman RO, Williams ME, Mohrbacher A, Weaver R, Dowden S, Levy R. Single-agent monoclonal antibody efficacy in bulky non-Hodgkin's lymphoma: results of a phase II trial of rituximab. J Clin Oncol. 1999 Jun;17(6):1851-7. doi: 10.1200/JCO.1999.17.6.1851. PMID 10561225
- BACKGROUNDMcLaughlin P, Grillo-Lopez AJ, Link BK, Levy R, Czuczman MS, Williams ME, Heyman MR, Bence-Bruckler I, White CA, Cabanillas F, Jain V, Ho AD, Lister J, Wey K, Shen D, Dallaire BK. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998 Aug;16(8):2825-33. doi: 10.1200/JCO.1998.16.8.2825. PMID 9704735
- BACKGROUNDKimby E. Tolerability and safety of rituximab (MabThera). Cancer Treat Rev. 2005 Oct;31(6):456-73. doi: 10.1016/j.ctrv.2005.05.007. Epub 2005 Jul 28. PMID 16054760
- BACKGROUNDKelesidis T, Daikos G, Boumpas D, Tsiodras S. Does rituximab increase the incidence of infectious complications? A narrative review. Int J Infect Dis. 2011 Jan;15(1):e2-16. doi: 10.1016/j.ijid.2010.03.025. Epub 2010 Nov 11. PMID 21074471
- BACKGROUNDvan Oers MH, Klasa R, Marcus RE, Wolf M, Kimby E, Gascoyne RD, Jack A, Van't Veer M, Vranovsky A, Holte H, van Glabbeke M, Teodorovic I, Rozewicz C, Hagenbeek A. Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood. 2006 Nov 15;108(10):3295-301. doi: 10.1182/blood-2006-05-021113. Epub 2006 Jul 27.