Study on Lenalidomide and Vaccine Therapy for Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT01351896

Provider View

This clinical trial is exploring whether combining lenalidomide with a vaccine can help treat patients with early-stage chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not yet have symptoms. The study aims to see if this combination can boost the immune system to better fight cancer cells.

Patient Parameters

Program Overview

The purpose of this study is to test if using lenalidomide, a drug that may block cancer growth and boost the immune system, together with a vaccine can create a stronger immune response to kill cancer cells in patients with early-stage chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not have symptoms yet. The study will compare two approaches: giving the vaccine and lenalidomide at the same time or one after the other.

Description

The main goal of this study is to see how many patients with early-stage, high-risk chronic lymphocytic leukemia (CLL) respond to treatment after receiving two doses of a pneumococcal vaccine (Prevnar 13) along with low-dose lenalidomide. Researchers will measure the response by checking specific antibody levels in the blood.

Secondary goals include:

  • Determining the complete response rate after two years of lenalidomide treatment.
  • Measuring the time until patients need another treatment for CLL.
  • Checking the rate of infections after treatment.
  • Evaluating the immune response to CLL tumor antigens.
  • Assessing the safety and side effects of long-term lenalidomide use.

Participants will be randomly assigned to one of two groups:

  • Group A will receive lenalidomide and the vaccine at the same time.
  • Group B will receive the vaccine first, followed by lenalidomide.

Both groups will take lenalidomide daily for 28-day cycles, repeating for at least 24 cycles unless the disease progresses or side effects become unacceptable. Participants will also receive the vaccine at specific times during the study.

Participants may have bone marrow biopsies, CT scans, and blood tests throughout the study. After completing the treatment, follow-up visits will occur for up to a year, then every six months.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Cancer cells must show certain high-risk genetic features.
  • Must not need immediate treatment for CLL/SLL based on specific medical criteria.
  • No previous treatment for CLL/SLL.
  • Aged 18 to 80 years old, with exceptions for those over 80 if justified.
  • Expected to live more than 24 months.
  • Must be in good general health with specific blood test results within normal ranges.
  • Must be able to swallow capsules and have no significant digestive issues.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control methods.
  • Men must agree to use condoms during sexual activity with women of childbearing potential.

Exclusion Criteria

  • Previous treatment for CLL/SLL.
  • Recent use of corticosteroids, except for low-dose maintenance therapy.
  • Currently meet criteria for needing CLL/SLL treatment.
  • Participation in other clinical trials.
  • Recent history of blood clots.
  • Allergic reactions to similar drugs or vaccine components.
  • Other cancers, except for certain skin or cervical cancers.
  • Uncontrolled illnesses or psychiatric conditions.
  • Pregnant or breastfeeding women.
  • HIV-positive patients on certain antiviral therapies.
  • Recent treatment for autoimmune blood disorders.
  • History of specific skin reactions to similar drugs.
  • Use of certain medications that may affect vaccine response.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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