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Immunomodulatory Agent

Lenalidomide + Vaccine for Chronic Lymphocytic Leukemia

Q: Is the age limit set for this investigation confined to participants under 25 years of age?

<p>The requirements for joining this medical trial stipulate that patients must be at least 18 years old and no older than 79.</p>

Phase 2

Waitlist Available

Led By Kerry Rogers

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

CLL/SLL cells must demonstrate high-risk genomic features such as Deletion (Del) (17p13.1), Del(11q22.3), complex karyotype, or unmutated immunoglobulin variable heavy chain (IgVH)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial studies the effect of lenalidomide and vaccine therapy in treating patients with early-stage asymptomatic chronic lymphocytic leukemia or small lymphocytic lymphoma.

Who is the study for?

This trial is for patients with early-stage, asymptomatic chronic lymphocytic leukemia or small lymphocytic lymphoma who have high-risk genomic features but haven't had previous CLL/SLL treatments. Participants must be in good health with proper organ function and no history of certain conditions like uncontrolled illness or recent deep vein thrombosis.Check my eligibility

What is being tested?

The study tests the combination of lenalidomide, a drug that may inhibit cancer growth and stimulate the immune system, with a pneumococcal vaccine designed to boost the body's ability to fight cancer cells. The goal is to see if this combo can create a stronger immune response against cancer.See study design

What are the potential side effects?

Lenalidomide might cause side effects such as blood clots, fatigue, diarrhea, rash or itching. The vaccine could lead to injection site reactions, fever or chills. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with CLL or SLL according to WHO standards.

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My CLL/SLL cancer cells show high-risk genetic changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients who achieve an antibody response

Secondary outcome measures

Serotyping

Change in anti-tumor antibody levels

Change in serum immunoglobulin

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (Sequential PCV13 and lenalidomide)Experimental Treatment4 Interventions

Patients receive PCV13 IM on days 1 and 78 (cycles 1 and 3). Patients also receive low-dose lenalidomide as in arm 1 beginning on day 1 of course 4. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (Concurrent PCV13 and lenalidomide)Experimental Treatment4 Interventions

Patients receive low-dose lenalidomide PO once daily on days 1-28. Treatment repeats every 28 days for at least 24 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive PCV13 IM on day 1 of courses 3 and 5.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~1480

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,105 Total Patients Enrolled

Kerry RogersPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01351896 — Phase 2

Chronic Lymphocytic Leukemia Research Study Groups: Arm A (Concurrent PCV13 and lenalidomide), Arm B (Sequential PCV13 and lenalidomide)

Chronic Lymphocytic Leukemia Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01351896 — Phase 2

Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01351896 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What do healthcare professionals usually employ Pneumococcal Polyvalent Vaccine to address?

"Pneumococcal Polyvalent Vaccine is frequently administered to individuals who have received at least two prior courses of systemic chemotherapy. Furthermore, this vaccine has demonstrated efficacy in treating patients with multiple myeloma and follicular lymphoma that had been previously treated."

Answered by AI

Has the Pneumococcal Polyvalent Vaccine been accredited by the FDA?

"Our researchers at Power rate the safety of Pneumococcal Polyvalent Vaccine a 2 due to the absence of efficacy data, which is typical for phase 2 trials."

Answered by AI

How many participants is this research project accommodating?

"This clinical trial is no longer accepting patients. It was initially posted on September 8th 2011, with the last edit made to it occurring July 27th 2022. However, there are still 2865 trials open for enrolment that involve antilymphocyte immunoglobulin and a further 287 studies actively recruiting patients who require Pneumococcal Polyvalent Vaccine treatment."

Answered by AI

Could you provide an overview of the past experiments with Pneumococcal Polyvalent Vaccine?

"At this moment, there are 287 studies being conducted on Pneumococcal Polyvalent Vaccine; 60 of which have advanced to the third phase. While most trials take place in Mishawaka, Indiana, a total of 13542 locations host relevant clinical research for this therapy."

Answered by AI

Is enrollment in this research program still open?

"Clinicaltrials.gov reports that this investigation, which first appeared on the platform in September 2011 and last updated July 2022, is not accepting new patients at present. Nevertheless, there are still 3152 other medical trials actively recruiting participants."

Answered by AI

Who is the ideal candidate for enrollment in this research project?

"This clinical trial is recruiting 48 individuals who are 18 to 79 years old and have antilymphocyte immunoglobulin. Other prerequisites include: palpable splenomegaly or lymphadenopathy, a histologically-verified diagnosis of CLL/SLL, fluorescent in-situ hybridization indicating deletion (17p13.1) on > 20% of cells, complex karyotype (>3 cytogenetic abnormalities), unmutated IgVH sequence homology at >= 98%, progressive leukocytosis with WBC count over 300k/uL, anemia (<11 g/dL) or th"

Answered by AI