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Cancer Vaccine
Pneumococcal Vaccination for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Seema A Bhat, MD
Research Sponsored by Seema Bhat
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treatment naive CLL/SLL; No prior therapy for CLL/SLL, including chemotherapy and/or radiotherapy is allowed
Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms
Must not have
History of allogenic stem cell transplantation
Active malignancy from which the subject is considered by his or her physician to have a less than 5-year survival expectation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
Summary
This trial is testing whether an initial vaccination, followed by yearly vaccinations, is more effective than the standard 5 year vaccination schedule for patients with chronic lymphocytic leukemia.
Who is the study for?
Adults diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma who haven't had previous treatments can join. They should have a life expectancy over 24 months, not be on certain immune system drugs, and must understand the study to give consent. Those with recent chemotherapy, vaccinations, very low lymphocyte counts, severe immune deficiencies, HIV infection or other serious illnesses cannot participate.
What is being tested?
The trial is testing two anti-pneumococcal vaccine schedules in patients with chronic lymphocytic leukemia: one involves initial vaccination followed by yearly shots; the other uses the standard five-year schedule. The goal is to see if more frequent vaccines offer better protection against pneumonia.
What are the potential side effects?
Possible side effects from pneumococcal vaccines include pain at the injection site, fatigue, headache, muscle pain, joint pain and fever. Severe allergic reactions are rare but may occur in some individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never received treatment for my CLL/SLL.
Select...
I have been diagnosed with CLL or SLL according to WHO standards.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a stem cell transplant from a donor.
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My doctor thinks I have less than 5 years to live due to my cancer.
Select...
I haven't taken strong immune system suppressants or high-dose steroids in the last 14 days.
Select...
I have a low white blood cell count or received rituximab in the last 6 months.
Select...
I have received IVIG treatment within the last 3 months.
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I am willing and able to follow all study requirements.
Select...
I understand the study's purpose and risks and can sign the consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (Experimental ARM-Annual Booster)Experimental Treatment2 Interventions
Patients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: PCV23 booster vaccination dose will be administered yearly for 5 years. Pre-vaccination and post-vaccination (at 4 weeks) titers will be checked each time yearly for 5 years.
Group II: Arm B (Experimental ARM-No Booster)Experimental Treatment2 Interventions
Patients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: None. Annual titers will be checked for 5 years.
Group III: Arm A (Standard ARM- No Booster)Active Control1 Intervention
Patients receive PCV 20 IM at week 0. Titers will be checked 4 weeks after this dose. Booster Vaccine: None. Titers will be checked at 12 weeks and then yearly for 5 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pneumococcal 20-valent Conjugate Vaccine
2022
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
Seema BhatLead Sponsor
Seema A Bhat, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had cellular therapy like CAR-T in the last 12 months.I will stop taking H2-blockers before starting the treatment.I have not had a fever over 38°C in the past week.I have never received treatment for my CLL/SLL.I do not have any ongoing illnesses or social situations that would prevent me from following the study's requirements.I have had a stem cell transplant from a donor.I am 18 years old or older.My doctor thinks I have less than 5 years to live due to my cancer.I haven't taken strong immune system suppressants or high-dose steroids in the last 14 days.I have been diagnosed with CLL or SLL according to WHO standards.I have a low white blood cell count or received rituximab in the last 6 months.I have received IVIG treatment within the last 3 months.I haven't had a serious infection or finished treatment for one in the last 14 days.I haven't had chemotherapy in the last 4 weeks or Rituximab in the last 6 months.I have received a pneumococcal vaccine in the last year.I am willing and able to follow all study requirements.I understand the study's purpose and risks and can sign the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (Standard ARM- No Booster)
- Group 2: Arm B (Experimental ARM-No Booster)
- Group 3: Arm C (Experimental ARM-Annual Booster)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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