Phase 2
N=65
Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
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
Bottom Line
View on ClinicalTrials.gov: NCT01145495 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Number of Participants Who Achieved a Complete Response — 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Lenalidomide (Drug); Rituximab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved a Complete Response |
47 | — |
| SECONDARY Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
51; 24; 21; 1; 14; 6 | — |
| SECONDARY Disease Progression |
0.86; 0.81; 0.74; 0.72 | — |
| SECONDARY Best Response |
47; 15; 1; 2 | — |
Summary
This phase II trial studies how well lenalidomide and rituximab work in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide together with rituximab may kill more cancer cells.
Eligibility Criteria
Inclusion Criteria
- Previously untreated, histologically confirmed follicular lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass >= 7 cm in any uni-dimensional measurement) stage II
- 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 CD20 antigen expression
- Low or intermediate risk by Follicular Lymphoma International Prognostic Index (FLIPI): 0-2 risk factors
- No prior systemic therapy for NHL, including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy); patients may have received involved-field radiation therapy
- No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease
- Eastern Cooperative Oncology Group (ECOG) performance status = 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)
- No known central nervous system (CNS) involvement by lymphoma
- 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 = 1,000/microliter
- Platelet count >= 75,000/microliter
- Creatinine clearance >= 30 mL/min unless attributable to NHL; to be calculated by method of Cockcroft-Gault, using actual weight; maximum creatinine clearance (CrCl) 125 mL/min
- Total bilirubin =< 2 times upper limit of normal (ULN) unless attributable to NHL or Gilbert disease
Data sourced from ClinicalTrials.gov (NCT01145495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.