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

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

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 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.

Key Dates

Start date

Jan 12, 2015

Status verified

May 2026

Primary completion

Dec 7, 2021

Completion

Jan 5, 2023

Study Design

Enrollment

37 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (ibrutinib)
  Patients receive ibrutinib orally PO 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.

Primary Outcome Measure

Determine the Progression-free Survival (PFS) Rate After 3 Years [ Time Frame: Assessed at 3 years ]

Locations (5)

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