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Tyrosine Kinase Inhibitor

Ibrutinib for Chronic Lymphocytic Leukemia

Phase 1
Waitlist Available
Led By Daniel A Pollyea
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of lenalidomide when given with ibrutinib to treat patients with CLL or SLL that has returned or does not respond to treatment.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Prolymphocytic Leukemia
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose of lenalidomide when combined with ibrutinib
Secondary outcome measures
Remission/response duration
Response rates
Other outcome measures
Ability of ibrutinib to bind to its targets
Change in Rho guanosine triphosphate (GTP)ase levels
Non-compartmental areas under the curve (AUCs) for ibrutinib
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib and lenalidomide)Experimental Treatment2 Interventions
Patients receive a run-up cycle of ibrutinib PO daily on days 1-28. Patients then receive ibrutinib PO and lenalidomide PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients who have achieved CR/CRi, nodular PR, partial remission with persistent lymphocytosis, partial remission, or who have stable disease discontinue lenalidomide and continue ibrutinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,414 Total Patients Enrolled
Daniel A PollyeaPrincipal InvestigatorUniversity of Colorado, Denver

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
2013. "Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01886859.
~2 spots leftby Apr 2025
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