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New treatment option for Chronic Lymphocytic Leukemia
Official title Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial
ClinicalTrials.gov ID: NCT05183854
What this study is testing
What is Pneumococcal 20-valent Conjugate Vaccine?
Pneumococcal 20-valent Conjugate Vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as PCV 20, PCV 20 Vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- NAIVE COHORT: people must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred...
- NAIVE COHORT: Male or female subject aged \>= 18 years.
- NAIVE COHORT: people must not have received prior therapy for CLL.
- VENETOCLAX-TREATMENT COHORT: people must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)...
- VENETOCLAX-TREATMENT COHORT: people must have received venetoclax (any dose) for at least 12 months with the last dose =\< 12 months prior to...
You likely can't join if
- people who have experienced a severe allergic reaction to prior pneumococcal vaccination.
- people 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);
See the full eligibility criteria
- NAIVE COHORT: people 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...
- NAIVE COHORT: Male or female subject aged \>= 18 years.
- NAIVE COHORT: people must not have received prior therapy for CLL.
- VENETOCLAX-TREATMENT COHORT: people 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...
- VENETOCLAX-TREATMENT COHORT: people must have received venetoclax (any dose) for at least 12 months with the last dose =\< 12 months prior to registration.
- people who have experienced a severe allergic reaction to prior pneumococcal vaccination.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.