Clinical trial · Interventional
Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial
Phase II Study of the Efficacy of the Pneumococcal Pneumonia Vaccine Series in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency (PROTECT CLL)
NCT05183854CI-TRIAL-00107786recruitingPhase 2ClinicalTrials.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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pneumococcal 20-valent Conjugate Vaccine | Biological | — | UNRESOLVED |
| Pneumococcal Polyvalent Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (PCV20, PPSV23)
- description
- Patients receive pneumococcal 20-valent conjugate vaccine IM on day 1. PnumoVax23 will be given as an intramuscular injection on Visit 2 (approximately Day 75)
- interventionNames
- Biological: Pneumococcal 20-valent Conjugate Vaccine
- Biological: Pneumococcal Polyvalent Vaccine
- type
- EXPERIMENTAL
- label
- Arm II (PCV20, PPPSV23)
- description
- Patients who have received or are receiving venetoclax therapy, receive pneumococcal 20-valent conjugate vaccine IM at study visit 1 and pneumococcal polyvalent vaccine IM at study visit 2 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: Pneumococcal 20-valent Conjugate Vaccine
- Biological: Pneumococcal Polyvalent Vaccine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (20)
- BACKGROUNDHowlader N, Noone A, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2016. Vol. 2020. Bethesda, MD: National Cancer Institute; 2019.
- BACKGROUNDFAIRLEY 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
- BACKGROUNDRavandi 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
- BACKGROUNDMolica 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
- BACKGROUNDMorrison 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
- BACKGROUNDRubin 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
- BACKGROUNDSinisalo 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
- BACKGROUNDItala 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.