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

Running, not enrolling · Phase 1

Conditions studied: 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

In brief

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 facts

Study ID

NCT01829568

Run by

National Cancer Institute (NCI)

People needed

33

Starts

2013-06-26

Expected to finish

2027-06-06

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously untreated, histologically confirmed follicular lymphoma, World Health Organization (WHO) classification grade I, II, or IIIa (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass >= 7 cm in any unidimensional measurement) stage II and requires therapy at the discretion of the primary physician
• Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable for diagnosis
• Failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
• Institutional flow cytometry or immunohistochemistry must confirm cluster of differentiation 20 (CD20) antigen expression
• All risk by follicular lymphoma international prognostic index (FLIPI): 0-5 risk factors
• No prior systemic therapy for non-Hodgkin lymphoma (NHL) including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy), radiation therapy, or radioimmunotherapy
• For non-NHL conditions, no chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of enrollment; no patients who have ongoing adverse events from agents administered more than 4 weeks previously
• No prior exposure to any of the study agents
• No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease; dose of corticosteroid or prednisone (or its equivalent) should not exceed 20 mg per day; corticosteroid premedication for rituximab is allowed
• Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2
• Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1 cm is acceptable; lesions that are considered non-measurable include the following:
• Bone lesions (lesions if present should be noted)
• Ascites
• Pleural/pericardial effusion
• Lymphangitis cutis/pulmonis
• Bone marrow (involvement by NHL should be noted)
• Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following:
• No evidence of coinfection with hepatitis B or C
• CD4+ cell count >= 400/mm\^3
• No evidence of resistant strains of HIV
• If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV ribonucleic acid (RNA)/mL
• If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL
• No history of acquired immunodeficiency syndrome (AIDS)-defining conditions
• No use of strong cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5) inhibitors or inducers
• No known central nervous system (CNS) involvement by lymphoma

Where it is running

• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• NYP/Weill Cornell Medical Center — New York, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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