Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial

Официальное название

Phase II Study of the Efficacy of the Pneumococcal Pneumonia Vaccine Series in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency (PROTECT CLL)

Обзор

This phase II trial tests whether the pneumococcal pneumonia vaccine series (PCV20 and PPSV23) works to mount an effective immune response in patients with chronic lymphocytic leukemia. PCV20 and PPSV23 are both vaccines that protect against bacteria that cause pneumococcal disease. Giving these vaccinations as series may make a stronger immune response and prevent against pneumococcal infections in patients with chronic lymphocytic leukemia. This is a single-center trial, conducted at Huntsman Cancer Institute.

Вмешательства

• Биопрепарат Pneumococcal 20-valent Conjugate Vaccine
  Given IM
• Биопрепарат Pneumococcal Polyvalent Vaccine
  Given IM

Первичные конечные точки

• Proportion of patients who achieve the protocol defined change in antibody titers [Срок оценки: At 30 and 90 days post-PCV20 vaccination]

Вторичные конечные точки (4)

• Proportion of patients who have a two-fold increase of immunoglobulin levels [Срок оценки: Up to 5 years post- PPSV23 vaccination]
• Proportion of vaccinated patients who have a two-fold increase in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines [Срок оценки: Up to 5 years post PPSV23 vaccination]
• Proportion of patients who have a two-fold increase in antibody titers to an individual serotype vaccination [Срок оценки: At 30 and 90 days post-PCV20 vaccination]
• Proportion of patients who maintain adequate immune response [Срок оценки: Up to 5 years post PPSV23 vaccination]

Критерии участия

Критерии включения

• NAIVE COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
• NAIVE COHORT: Male or female subject aged >= 18 years.
• NAIVE COHORT: Subjects must not have received prior therapy for CLL.
• VENETOCLAX-TREATMENT COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
• VENETOCLAX-TREATMENT COHORT: Subjects must have received venetoclax (any dose) for at least 12 months with the last dose =< 12 months prior to registration.

Критерии исключения

• Subjects who have experienced a severe allergic reaction to prior pneumococcal vaccination.
• Subjects who have received a PCV13 or PCV20 pneumococcal vaccination in the last five years.

• If they have received PPSV23 in ≥ 1 year and no other pneumococcal vaccine they may be included.
• Active infection requiring systemic antibiotic therapy.
• Current or prior use of immunosuppressive medication within 14 days of cycle one day one, EXCEPT for the following permitted steroids:

• Intranasal, inhaled, topical steroids, eye drops or local steroid injection (e.g., intra-articular injection);
• Systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent;
• Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] scan premedication).
• Concurrent illness or condition, which, in the opinion of the treating investigator, would negatively impact the subject's study participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Huntsman Cancer Institute/University of Utah — Salt Lake City

Публикации

• Howlader N, Noone A, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2016. Vol. 2020. Bethesda, MD: National Cancer Institute; 2019.
• FAIRLEY GH, SCOTT RB. Hypogammaglobulinaemia in chronic lymphatic leukaemia. Br Med J. 1961 Oct 7;2(5257):920-4. doi: 10.1136/bmj.2.5257.920. No abstract available. PMID 13697946
• Ravandi F, O'Brien S. Immune defects in patients with chronic lymphocytic leukemia. Cancer Immunol Immunother. 2006 Feb;55(2):197-209. doi: 10.1007/s00262-005-0015-8. Epub 2005 Jul 16. PMID 16025268
• Molica S, Levato D, Levato L. Infections in chronic lymphocytic leukemia. Analysis of incidence as a function of length of follow-up. Haematologica. 1993 Nov-Dec;78(6):374-7. PMID 8175032
• Morrison VA. Infectious complications of chronic lymphocytic leukaemia: pathogenesis, spectrum of infection, preventive approaches. Best Pract Res Clin Haematol. 2010 Mar;23(1):145-53. doi: 10.1016/j.beha.2009.12.004. PMID 20620978
• Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014 Feb;58(3):309-18. doi: 10.1093/cid/cit816. PMID 24421306
• Sinisalo M, Aittoniemi J, Oivanen P, Kayhty H, Olander RM, Vilpo J. Response to vaccination against different types of antigens in patients with chronic lymphocytic leukaemia. Br J Haematol. 2001 Jul;114(1):107-10. doi: 10.1046/j.1365-2141.2001.02882.x. PMID 11472353
• Itala M, Helenius H, Nikoskelainen J, Remes K. Infections and serum IgG levels in patients with chronic lymphocytic leukemia. Eur J Haematol. 1992 May;48(5):266-70. doi: 10.1111/j.1600-0609.1992.tb01805.x. PMID 1644158

Идентификаторы

NCT: NCT05183854 · HCI145280 · NCI-2021-13373 · HCI145280

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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