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Secondary Immune Deficiency DisorderPhase 2/3NCT03730129

Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig

A Phase 2/3 study testing Hizentra in people with Secondary Immune Deficiency Disorder, run by Rochester General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Secondary Immune Deficiency Disorder
What is being tested?
Hizentra
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
5 Nov 2018to 3 Jul 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Allergy, Immunology, Rheumatology at Rochester Regional Health

    Rochester, New York, 14607

Other trials in United States

About this study

Official title: A Prospective Case Series of Subcutaneous Immunoglobulin for Prophylaxis of Infections in Patients With Chronic Lymphocytic Leukemia With Impaired Humoral Immunity

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.

Being tested
Hizentra
Keywords
chronic lymphocytic leukemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HizentraDrug

    Subjects will receive Hizentra 0.4 mg/kg qweekly subcutaneously for 6 months (24 weeks)

Study groups in NCT03730129
Study groupRoleWhat they receive
Ig replacementExperimentalSubjects will receive Hizentra 0.4 mg/kg subq once weekly.
Receives: Drug: Hizentra

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify patients with CLL with humoral immunodeficiency despite serum IgG > 500 mg/dL.

    Incidence of humoral immunodeficiency

    Measured: 10 months

  2. Number of patients who increase IgG to above 700 mg/dL

    Effectiveness of Hizentra to change IgG levels

    Measured: 10 months

Secondary outcomes (4)

  1. Number of patients who increase diphtheria IgG to above 0.1 IU/mL, tetanus IgG to above 0.1 IU/mL, and IgG to streptococcus pneumonia to above 1.3 mcg/mL

    Effectiveness of Hizentra to change specific antibody titers in CLL

    Measured: 10 months

  2. Number of subjects with treatment-related adverse effects as assessed by CTCAE v4.0

    Safety and tolerability of Hizentra in CLL

    Measured: 10 months

  3. Quality of life (Short Form 36) on subcutaneous Ig replacement therapy a 0-100 scale, with lower scores indicating higher disability/lower quality of life

    Does Hizentra change quality of life scores in patients with CLL

    Measured: 10 months

  4. Track the number of infections requiring antibiotics, further characterized per severity as defined in previous studies

    Does Hizentra change the rate of non-neutropenic infections in CLL

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2018
  2. Study start5 Nov 2018
  3. Primary completion3 Jul 2020
  4. Study completion3 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03730129
Sponsor's protocol ID
CIC1850-A-18
Status last verified
Aug 2020
First submitted
11 Oct 2018
Last updated
26 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Twomey JJ. Infections complicating multiple myeloma and chronic lymphocytic leukemia. Arch Intern Med. 1973 Oct;132(4):562-5. No abstract available.

    PubMed 4542660

  • Oscier 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.

    PubMed 23057493

  • Lachance 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.

    PubMed 26966403

  • Chapel 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.

    PubMed 7803248

  • Dicato 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.

    PubMed 1878842

  • Molica 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.

    PubMed 8641639

  • Raanani 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.

    PubMed 18843719

  • Dhalla F, Lucas M, Schuh A, Bhole M, Jain R, Patel SY, Misbah S, Chapel H. Antibody deficiency secondary to chronic lymphocytic leukemia: Should patients be treated with prophylactic replacement immunoglobulin? J Clin Immunol. 2014 Apr;34(3):277-82. doi: 10.1007/s10875-014-9995-5. Epub 2014 Feb 21.

    PubMed 24557494

  • Ueda M, Berger M, Gale RP, Lazarus HM. Immunoglobulin therapy in hematologic neoplasms and after hematopoietic cell transplantation. Blood Rev. 2018 Mar;32(2):106-115. doi: 10.1016/j.blre.2017.09.003. Epub 2017 Sep 19.

    PubMed 28958644

  • Sanchez-Ramon S, Dhalla F, Chapel H. Challenges in the Role of Gammaglobulin Replacement Therapy and Vaccination Strategies for Hematological Malignancy. Front Immunol. 2016 Aug 22;7:317. doi: 10.3389/fimmu.2016.00317. eCollection 2016.

    PubMed 27597852

  • Friman V, Winqvist O, Blimark C, Langerbeins P, Chapel H, Dhalla F. Secondary immunodeficiency in lymphoproliferative malignancies. Hematol Oncol. 2016 Sep;34(3):121-32. doi: 10.1002/hon.2323. Epub 2016 Jul 12.

    PubMed 27402426

  • Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia; Gale RP, Chapel HM, Bunch C, Rai KR, Foon K, Courter SG, Tait D. Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. A randomized, controlled clinical trial. N Engl J Med. 1988 Oct 6;319(14):902-7. doi: 10.1056/NEJM198810063191403.

    PubMed 2901668

  • Looney RJ, Huggins J. Use of intravenous immunoglobulin G (IVIG). Best Pract Res Clin Haematol. 2006;19(1):3-25. doi: 10.1016/j.beha.2005.01.032.

    PubMed 16377538

  • Berger M. Adverse effects of IgG therapy. J Allergy Clin Immunol Pract. 2013 Nov-Dec;1(6):558-66. doi: 10.1016/j.jaip.2013.09.012. Epub 2013 Oct 31.

    PubMed 24565701

  • Gardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2):105-16. doi: 10.2165/00063030-200721020-00005.

    PubMed 17402794

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Hizentra in people with Secondary Immune Deficiency Disorder, run by Rochester General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify patients with CLL with humoral immunodeficiency despite serum IgG > 500 mg/dL. (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03730129, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.

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