NCT02649387

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

Minimal Residual Disease Eradication With Ibrutinib Therapy (MERIT) in Patients With Chronic Lymphocytic Leukemia After Frontline Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine the rate of minimal residual disease (MRD)-negative responses (in both blood and bone marrow) at any time during treatment with ibrutinib maintenance. SECONDARY OBJECTIVES: I. Median time to achieve MRD- (negative) status (in blood and in bone marrow) after initiation of ibrutinib maintenance treatment. II. Toxicity profile of ibrutinib as maintenance therapy after frontline induction. III. Durability of the MRD- state (determined from the time of first documentation of MRD- until the first documentation of MRD+ (positive) (or last date shown to be MRD- for a censor). IV. Determine the number of patients who improve their remission category (i.e., upgrade clinical response achieved after the induction such as from partial response \[PR\] to complete response \[CR\]) after initiating the maintenance therapy. V. Time to requirement of next therapy for patients who achieve confirmed MRD- vs. those who remain MRD+ disease at 48 weeks (end of 12 cycles). VI. Progression free survival (as determined by the International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] criteria) among patients who achieve confirmed MRD- vs. those who remain MRD+ disease at 48 weeks (end of 12 cycles). TERTIARY OBJECTIVES: I. To conduct correlative studies for further understanding of the mechanism of antitumor activity of ibrutinib in eradication of the MRD. II. Determine the impact of ibrutinib on depression and anxiety symptoms to better understand toxicity profile of ibrutinib maintenance. III. Determine impact of social support or lack thereof on mood symptoms in chronic lymphocytic leukemia (CLL) patients receiving maintenance treatment. OUTLINE: Patients receive ibrutinib orally (PO) once daily (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. After completion of study treatment, patients are followed up every 3-6 months for up to 2 years.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2016-02-08
• Primary completion: 2023-12-14
• Completion: 2026-01-15
• First posted: 2016-01-07
• Last updated: 2026-02-10
• Results posted: 2025-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study