NCT01829568Active, not recruitingPhase 1

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

A Phase I Study of Rituximab, Lenalidomide, and Ibrutinib in Previously Untreated Follicular Lymphoma

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 33 (actual)
First submitted: 9 Apr 2013
Start date: 26 Jun 2013
Primary completion date: 11 May 2015
Lead sponsor: National Cancer Institute (NCI)
Diseases: Follicular lymphoma
NCT number: NCT01829568

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 33
From 26 Jun 2013 to the primary completion date, 11 May 2015
7 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

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
No treatment with strong inhibitors or inducers of CYP3A4/5
No evidence of active hepatitis B or C infections (i.e., no positive serology for anti-hepatitis B virus \[HBV\] or anti-hepatitis C virus \[HCV\] antibodies); HBV seropositive patients (hepatitis B surface antigen \[HBsAg\] +) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxyribonucleic acid (DNA) testing and receive suppressive therapy with lamivudine or other HBV suppressive therapy until 6 months after the last rituximab dose
No history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome
No history of uncontrolled seizures
No autoimmune disorder that requires active immunosuppression
No intracranial hemorrhage within the last 6 months
Patients must be non-pregnant and non-nursing; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days and again within 24 hours prior to starting cycle 1 of lenalidomide; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure
No known human anti-chimeric antibody (HACA) positivity
No anticoagulation with warfarin is allowed; patients must not have received warfarin within 28 days prior to registration; alternative anticoagulant may be used
Patients must not be receiving concurrent treatment with other investigational drugs
Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide, ibrutinib, or other agents used in study
Patients must not have presence of transfusion-dependent thrombocytopenia
No currently active clinically significant cardiovascular disease including the following:
- No uncontrolled arrhythmia
- No congestive heart failure
- No class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- No history of myocardial infarction, deep venous or arterial thrombosis within 6 months prior to registration
No prior malignancy with the exceptions listed below:
- Malignancy treated with curative intent and with no evidence of active disease for more than 3 years prior to screening and felt to be at low risk for recurrence by the treating physician
- Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease
- Adequately treated cervical carcinoma in situ without current evidence of disease
Patients must be \>= 18 years of age
Absolute neutrophil count (ANC) \>= 1,000/microliter (should be present independent of growth factor or transfusion support for at least 7 days prior to first dose of study drug)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) (should be present independent of growth factor or transfusion support for at least 7 days prior to first dose of study drug)
Total bilirubin =\< 1.5 x ULN unless attributable to Gilbert's syndrome (should be present independent of growth factor or transfusion support for at least 7 days prior to first dose of study drug)
Creatinine clearance \> 60 mL/min (patients on dialysis are not eligible); to be calculated by method of Cockcroft-Gault, using actual weight (should be present independent of growth factor or transfusion support for at least 7 days prior to first dose of study drug)
Creatinine =\< 2 x ULN (should be present independent of growth factor or transfusion support for at least 7 days prior to first dose of study drug)
Platelet count \>= 75,000/microliter (should be present independent of growth factor or transfusion support for at least 7 days prior to first dose of study drug)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Dana-Farber Cancer Institute Coordinator of this site? Confirm its status	Boston	United States	Unknown status
Roswell Park Cancer Institute Coordinator of this site? Confirm its status	Buffalo	United States	Unknown status
UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status	Chapel Hill	United States	Unknown status
University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status	Chicago	United States	Unknown status
Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status	Columbus	United States	Unknown status
NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status	New York	United States	Unknown status
MedStar Georgetown University Hospital Coordinator of this site? Confirm its status	Washington D.C.	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.