Ibrutinib in Treating Minimal Residual Disease in Patients With Chronic Lymphocytic Leukemia After Front-Line Therapy

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT02649387
Phase
PHASE2
Status
Completed

Conditions

  • Stage I Chronic Lymphocytic Leukemia
  • Stage II Chronic Lymphocytic Leukemia
  • Stage III Chronic Lymphocytic Leukemia
  • Stage IV Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies the side effects and how well ibrutinib works in treating patients with chronic lymphocytic leukemia who responded to initial treatment used to reduce a cancer (front-line therapy) but have residual disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Feb 8, 2016
Status verified
Jan 2026
Primary completion
Dec 14, 2023
Completion
Jan 15, 2026

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ibrutinib)
    Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks\* for up to 36 courses in the absence of disease progression or unacceptable toxicity. Note: \*The last course may last up to 56 days to accommodate the study drug discontinuation visit.

Primary Outcome Measure

Rate of Confirmed MRD-negative Response [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-

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Mayo Clinic in Florida· Jacksonville, FL