Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

Recruiting now · Phase 1

Conditions studied: Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System

In brief

This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).

Key facts

Study ID

NCT04609046

Run by

National Cancer Institute (NCI)

People needed

47

Starts

2021-05-24

Expected to finish

2027-04-01

Last updated by the study team

2026-07-30

Who can join

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

You may qualify if…

• Histologically proven primary CNS diffuse large b-cell lymphoma confirmed by one of the following:
• Brain biopsy or resection
• Cerebrospinal fluid
• Vitreous fluid
• No prior organ transplantation to exclude post-transplant lymphoproliferative disorders
• No prior chemotherapy or radiation therapy for lymphoma
• No prior allogeneic stem cell transplantation
• Use of systemic corticosteroids (dexamethasone up to 24 mg/day or equivalent) for disease control or improvement of performance status to be tapered as fast as clinically safe after initiation of therapy is permissible
• Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown and an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, female of childbearing potential (FCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) =< 7 days prior to registration
• Age >= 18 years
• Karnofsky performance scale (KPS) >= 40 (>= 50 for patients older than 60 unless related to lymphoma on investigator's opinion)
• Absolute neutrophil count (ANC) >= 1,500/mm\^3
• Platelet count >= 100,000/mm\^3
• Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault formula
• Total Bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
• No evidence of non-Hodgkin's lymphoma (NHL) outside CNS
• No prior history of NHL
• No history of autoimmune disorder. Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as Systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
• Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
• Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (except short course of systemic corticosteroids for disease control or improvement of performance status) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
• Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study
• No prior or concurrent malignancies with exception of surgically cured carcinoma in situ (CIS) of the uterus, carcinoma of the skin without evidence of disease for >= 5 years
• No concurrent malignancy requiring active therapy
• No untreated hepatitis C virus (HCV) infection with detectable HCV viral load

Where it is running

• Siteman Cancer Center-South County — St Louis, Missouri, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States (enrolling)
• MaineHealth Cancer Care and IV Therapy - South Portland — South Portland, Maine, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida, United States (enrolling)
• University of Miami Sylvester Comprehensive Cancer Center at Sole Mia — North Miami, Florida, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States (enrolling)
• UCSF Medical Center-Parnassus — San Francisco, California, United States (enrolling)
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (enrolling)
• Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States (enrolling)
• Iowa Methodist Medical Center — Des Moines, Iowa, United States (enrolling)
• UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States (enrolling)
• Broadlawns Medical Center — Des Moines, Iowa, United States (enrolling)
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States (enrolling)
• UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States (enrolling)
• UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States (enrolling)
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (enrolling)
• UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States (enrolling)
• Saint Anthony Regional Hospital — Carroll, Iowa, United States (enrolling)
• UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States (enrolling)
• Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States (enrolling)
• MaineHealth Maine Medical Center - Portland — Portland, Maine, United States (enrolling)
• MaineHealth Maine Medical Center- Scarborough — Scarborough, Maine, United States (enrolling)
• Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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