NCT02242097

Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma

A Phase II Clinical Trial Evaluating Ibrutinib Maintenance Following Intensive Induction for Patients With Previously Untreated Mantle Cell Lymphoma (MCL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to see whether or not a drug called ibrutinib can be given to patients with mantle cell lymphoma (MCL) as maintenance therapy after induction chemotherapy. This drug blocks an enzyme that affects how the lymphocytes grow and survive. The investigators hope to learn how safe and effective ibrutinib is for treating patients with MCL after responding to induction chemotherapy.

Detailed description

PRIMARY OBJECTIVES: I. To determine the progression-free survival (PFS) rate after 3 years. SECONDARY OBJECTIVES: I. Assess toxicity. II. Determine rates of conversion from partial response (PR) to complete response (CR). III. Determine median overall survival (OS) after 4 years. TERTIARY OBJECTIVES: I. Compare minimal residual disease (MRD) results overtime by polymerase chain reaction (PCR) and correlate these with PFS and OS. OUTLINE: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 4 years in the absence of disease progression, unacceptable toxicity or patient preference. After completion of study treatment, patients who completed 4 years of treatment are followed up at 30 days. Patients who did not complete 4 years of treatment are followed up for up to 4 years post-first dose of treatment (every 3 months for 2 years and then every 6 months for 4 years).

Conditions

• Contiguous Stage II Mantle Cell Lymphoma
• Noncontiguous Stage II Mantle Cell Lymphoma
• Stage I Mantle Cell Lymphoma
• Stage III Mantle Cell Lymphoma
• Stage IV Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	ibrutinib	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2015-01-12
• Primary completion: 2023-01-05
• Completion: 2025-01-01
• First posted: 2014-09-16
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

5 sites across 1 country: United States