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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

All Individual Drugs Already Approved

No Placebo-Only Group

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 below

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I have never received treatment for my CLL/SLL.

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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:

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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.

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I haven't taken strong immune system suppressants or high-dose steroids in the last 14 days.

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I have a low white blood cell count or received rituximab in the last 6 months.

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I have received IVIG treatment within the last 3 months.

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I am willing and able to follow all study requirements.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

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)

Awards & Highlights

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.

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

0 / 9Eligibility criteria met