Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

NCT03211065 | Completed Phase 2 FDA Drug

• 1 other identifier: BT16-34083
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Secondary Immune Deficiency

Keywords

Rituximab; Non Hodgkin's Lymphoma; Subcutaneous Immunoglobulin

Outcome Measures

Primary Outcomes (1)

• Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment

  How many antibiotics are prescribed in one year for any type of infection

  1 year

Secondary Outcomes (1)

• Quality of life score for participants during the one year enrollment

  1 year

Study Arms (1)

Immunoglobulin therapy

EXPERIMENTAL

Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.

Drug: 20% subcutaneous immunoglobulin

Interventions

20% subcutaneous immunoglobulin DRUG

Subcutaneous Immunoglobulin

Also known as: Cuvitru

Immunoglobulin therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of B cell non-Hodgkin's lymphoma
• Medically stable
• Able to understand and willingness to sign a written informed consent
• Able to comply with study procedures

You may not qualify if:

• Previously diagnosed primary immunodeficiency
• Additional immunosuppressive states
• Ongoing therapy with Ig replacement

Sponsors & Collaborators

• Rochester General Hospital: lead

Study Sites (1)

Allergy and Immunology, 222 Alexander Street

Rochester, New York, 14607, United States

Location

Related Publications (13)

• Kaplan 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 BACKGROUND

• Davis 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 BACKGROUND

• McLaughlin 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 BACKGROUND

• Kimby 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 BACKGROUND

• Kelesidis 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 BACKGROUND

• van 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.

  PMID: 16873669 BACKGROUND

• Casulo C, Maragulia J, Zelenetz AD. Incidence of hypogammaglobulinemia in patients receiving rituximab and the use of intravenous immunoglobulin for recurrent infections. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):106-11. doi: 10.1016/j.clml.2012.11.011. Epub 2012 Dec 29.

  PMID: 23276889 BACKGROUND

• Cabanillas F, Liboy I, Pavia O, Rivera E. High incidence of non-neutropenic infections induced by rituximab plus fludarabine and associated with hypogammaglobulinemia: a frequently unrecognized and easily treatable complication. Ann Oncol. 2006 Sep;17(9):1424-7. doi: 10.1093/annonc/mdl141.

  PMID: 16966368 BACKGROUND

• Duraisingham SS, Buckland M, Dempster J, Lorenzo L, Grigoriadou S, Longhurst HJ. Primary vs. secondary antibody deficiency: clinical features and infection outcomes of immunoglobulin replacement. PLoS One. 2014 Jun 27;9(6):e100324. doi: 10.1371/journal.pone.0100324. eCollection 2014.

  PMID: 24971644 BACKGROUND

• Makatsori M, Kiani-Alikhan S, Manson AL, Verma N, Leandro M, Gurugama NP, Longhurst HJ, Grigoriadou S, Buckland M, Kanfer E, Hanson S, Ibrahim MA, Grimbacher B, Chee R, Seneviratne SL. Hypogammaglobulinaemia after rituximab treatment-incidence and outcomes. QJM. 2014 Oct;107(10):821-8. doi: 10.1093/qjmed/hcu094. Epub 2014 Apr 28.

  PMID: 24778295 BACKGROUND

• Spadaro G, Pecoraro A, De Renzo A, Della Pepa R, Genovese A. Intravenous versus subcutaneous immunoglobulin replacement in secondary hypogammaglobulinemia. Clin Immunol. 2016 May;166-167:103-4. doi: 10.1016/j.clim.2016.04.001. Epub 2016 Apr 7.

  PMID: 27063866 BACKGROUND

• Compagno N, Cinetto F, Semenzato G, Agostini C. Subcutaneous immunoglobulin in lymphoproliferative disorders and rituximab-related secondary hypogammaglobulinemia: a single-center experience in 61 patients. Haematologica. 2014 Jun;99(6):1101-6. doi: 10.3324/haematol.2013.101261. Epub 2014 Mar 28.

  PMID: 24682509 BACKGROUND

• Cooper N, Arnold DM. The effect of rituximab on humoral and cell mediated immunity and infection in the treatment of autoimmune diseases. Br J Haematol. 2010 Apr;149(1):3-13. doi: 10.1111/j.1365-2141.2010.08076.x. Epub 2010 Feb 11.

  PMID: 20151975 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Hizentra

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• S Shahzad Mustafa, MD

  Rochester Regional Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Associate Medical Director

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 7, 2017
• Study Start: July 21, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 19, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)