Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma

Conditions

• Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma
• Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma
• Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma
• Ann Arbor Stage II Grade 2 Non-Contiguous Follicular Lymphoma
• Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma
• Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma
• Ann Arbor Stage III Grade 1 Follicular Lymphoma
• Ann Arbor Stage III Grade 2 Follicular Lymphoma
• Ann Arbor Stage III Grade 3 Follicular Lymphoma
• Ann Arbor Stage IV Grade 1 Follicular Lymphoma
• Ann Arbor Stage IV Grade 2 Follicular Lymphoma
• Ann Arbor Stage IV Grade 3 Follicular Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  Given PO
• Lenalidomide — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV

Study Details

This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib when given together with rituximab in treating patients with previously untreated stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving lenalidomide and ibrutinib together with rituximab may work well in treating follicular lymphoma.

Key Dates

Start date

Jun 26, 2013

Status verified

Dec 2025

Primary completion

May 11, 2015

Completion

Jun 6, 2026

Study Design

Enrollment

33 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (lenalidomide, ibrutinib, and rituximab)
  Patients receive lenalidomide PO QD on days 1-21 and ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, 15, and 22 of cycle 1 and once weekly at weeks 13, 21, 29, and 37.

Primary Outcome Measure

Maximally tolerated dose (MTD) of lenalidomide and ibrutinib for combination with rituximab [ Time Frame: 28 days ]

Locations (7)

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