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Bruton's Tyrosine Kinase (BTK) Inhibitor

Ibrutinib for High-risk CLL/SLL

Phase 2

Waitlist Available

Led By Jennifer Woyach, MD

Research Sponsored by Jennifer Woyach

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ibrutinib with different vaccine therapies to see if it is a better treatment for patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma who do not have any symptoms.

Who is the study for?

This trial is for patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma who haven't had previous treatment. They should have certain genetic markers, a life expectancy over 24 months, and be in relatively good health (ECOG <=2). Participants must not show signs needing immediate CLL/SLL treatment, have other serious illnesses or infections, or be on conflicting medications.

What is being tested?

The study tests if the drug Ibrutinib combined with vaccines (pneumococcal, influenza, diphtheria/tetanus/pertussis) can help treat asymptomatic high-risk CLL/SLL by enhancing the immune response to fight cancer cells. It's a phase II trial where participants are randomly assigned to receive this combination therapy.

What are the potential side effects?

Ibrutinib may cause side effects like diarrhea, bleeding problems, high blood pressure, fatigue and muscle pains. Vaccines could lead to injection site reactions, fever or mild flu-like symptoms. The severity of side effects varies from person to person.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Degree of response (CR MRD-,CR, PR, PR with lymphocytosis, and SD)

Incidence of adverse events, evaluated using the NCI CTCAE version 4.0

Proportion of patients who achieve complete response

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (sequential vaccines and ibrutinib)Experimental Treatment7 Interventions

Patients receive pneumococcal 13-valent conjugate vaccine IM on day 1 of courses 1 and 3 and trivalent influenza IM and DTaP vaccine IM on day 1 of course 2. Beginning in course 4, patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (concurrent vaccines and ibrutinib)Experimental Treatment7 Interventions

Patients receive ibrutinib PO QD on days 1-28. Patients also receive pneumococcal 13-valent conjugate vaccine IM on day 1 of courses 3 and 5 and trivalent influenza vaccine IM and DTaP vaccine IM on day 1 of course 4. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~2060

Trivalent Influenza Vaccine

2010

Completed Phase 4

~2800