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Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig
This study is not yet open for participant recruitment.
Verified July 2017 by S. Shahzad Mustafa, Rochester General Hospital
Sponsor:
Rochester General Hospital
Information provided by (Responsible Party):
S. Shahzad Mustafa, Rochester General Hospital
ClinicalTrials.gov Identifier:
NCT03211065
First received: July 3, 2017
Last updated: July 5, 2017
Last verified: July 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Secondary Immune Deficiency | Drug: 20% subcutaneous immunoglobulin | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by S. Shahzad Mustafa, Rochester General Hospital:
Primary Outcome Measures:
- Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment [ Time Frame: 1 year ]How many antibiotics are prescribed in one year for any type of infection
Secondary Outcome Measures:
- Quality of life score for participants during the one year enrollment [ Time Frame: 1 year ]Assessed with Short Form 36 (SF 36)
- Number of subjects with treatment-related adverse effects as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
- 1 year mortality [ Time Frame: 1 year ]
| Estimated Enrollment: | 10 |
| Anticipated Study Start Date: | July 2017 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immunoglobulin therapy
Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.
|
Drug: 20% subcutaneous immunoglobulin
Subcutaneous Immunoglobulin
Other Name: Cuvitru
|
Detailed Description:
The investigators propose evaluating patients with B cell non-Hodgkin's lymphoma treated with rituximab within the past 2 years with baseline immunoglobulin levels and vaccine responses to polysaccharide (pneumococcus, meningococcus) and peptide (tetanus, diphtheria) antigens. Patients with impaired vaccine responses may benefit most from immunoglobulin prophylaxis and will be proactively started on 20% subcutaneous replacement therapy. This study is novel in that it will stratify patients according to their humoral response to polysaccharide and peptide vaccines, and will proactively initiate therapy with the new 20% subcutaneous immunoglobulin in those with impaired humoral response rather than starting it after infections occur. This will potentially lead to decreased infections and improved quality of life.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previously diagnosed primary immunodeficiency
- Additional immunosuppressive states
- Ongoing therapy with Ig replacement
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211065
Please refer to this study by its ClinicalTrials.gov identifier: NCT03211065
Contacts
| Contact: Tia Albro, NP | 585-922-3536 | Tia.Albro@rochesterregional.org |
Sponsors and Collaborators
Rochester General Hospital
Investigators
| Principal Investigator: | S Shahzad Mustafa, MD | Rochester Regional Health |
More Information
Publications:
| Responsible Party: | S. Shahzad Mustafa, Physician, Associate Medical Director, Rochester General Hospital |
| ClinicalTrials.gov Identifier: | NCT03211065 History of Changes |
| Other Study ID Numbers: |
BT16-34083 |
| Study First Received: | July 3, 2017 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | Yes | |
Keywords provided by S. Shahzad Mustafa, Rochester General Hospital:
|
Rituximab Non Hodgkin's Lymphoma Subcutaneous Immunoglobulin |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Immune System Diseases Rituximab Immunoglobulins Antibodies |
Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on July 11, 2017