Spots Global Cancer Trial Database for Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma

Study Description

Brief 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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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