NCT04609046Active, not recruitingPhase 1
Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
Phase I Trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- First submitted
- 29 Oct 2020
- Start date
- 24 May 2021
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT04609046
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 47
- From 24 May 2021 to the primary completion date, 1 Aug 2027
- 56 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
- 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
- No untreated chronic hepatitis B virus (HBV) infection with detectable HBV viral load
- No untreated human immunodeficiency virus (HIV) infection or with detectable viral load or with CD4+T-cell count of less than 500/mm\^3
- No history of HIV infection and evidence of Epstein Barr virus (EBV)-related primary central nervous system lymphoma (PCNSL)
- Inability to tolerate anticoagulation with acetylsalicylic acid, warfarin, or direct oral anticoagulants
- No other investigational agent
- No history of severe hypersensitivity reaction to any monoclonal antibody
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to or other agents used in study
- Sulfonamide drugs, trimethoprim, salicylates, nonsteroidal anti-inflammatory drugs, penicillin, vitamin C, ciprofloxacin, and proton pump inhibitors should be held at least 48 hours prior to methotrexate administration
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hickman Cancer Center Coordinator of this site? Confirm its status | Adrian | United States | Unknown status |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic Coordinator of this site? Confirm its status | Ankeny | United States | Unknown status |
| Our Lady of the Lake Physician Group Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| LSU Health Baton Rouge-North Clinic Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| Saint Anthony Regional Hospital Coordinator of this site? Confirm its status | Carroll | United States | Unknown status |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Siteman Cancer Center at Saint Peters Hospital Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic Coordinator of this site? Confirm its status | Clive | United States | Unknown status |
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Siteman Cancer Center at West County Hospital Coordinator of this site? Confirm its status | Creve Coeur | United States | Unknown status |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Mercy Medical Center - Des Moines Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| UI Health Care Mission Cancer and Blood - Laurel Clinic Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Broadlawns Medical Center Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Iowa Methodist Medical Center Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Iowa Lutheran Hospital Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| UM Sylvester Comprehensive Cancer Center at Doral Coordinator of this site? Confirm its status | Doral | United States | Unknown status |
| Marshfield Medical Center-EC Cancer Center Coordinator of this site? Confirm its status | Eau Claire | United States | Unknown status |
| UI Healthcare Mission Cancer and Blood - Fort Dodge Coordinator of this site? Confirm its status | Fort Dodge | United States | Unknown status |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Gundersen Lutheran Medical Center Coordinator of this site? Confirm its status | La Crosse | United States | Unknown status |
| Northwell Health/Center for Advanced Medicine Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| UM Sylvester Comprehensive Cancer Center at Kendall Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Marshfield Medical Center - Minocqua Coordinator of this site? Confirm its status | Minocqua | United States | Unknown status |
| Toledo Clinic Cancer Centers-Monroe Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| West Virginia University Healthcare Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYP/Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Miami Sylvester Comprehensive Cancer Center at Sole Mia Coordinator of this site? Confirm its status | North Miami | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| UM Sylvester Comprehensive Cancer Center at Plantation Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| MaineHealth Maine Medical Center - Portland Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Marshfield Medical Center-Rice Lake Coordinator of this site? Confirm its status | Rice Lake | United States | Unknown status |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| UCSF Medical Center-Parnassus Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| MaineHealth Maine Medical Center- Scarborough Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| MaineHealth Cancer Care and IV Therapy - South Portland Coordinator of this site? Confirm its status | South Portland | United States | Unknown status |
| Marshfield Medical Center-River Region at Stevens Point Coordinator of this site? Confirm its status | Stevens Point | United States | Unknown status |
| Siteman Cancer Center at Christian Hospital Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Siteman Cancer Center-South County Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Overlook Hospital Coordinator of this site? Confirm its status | Summit | United States | Unknown status |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| Toledo Clinic Cancer Centers-Toledo Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| UI Health Care Mission Cancer and Blood - Waukee Clinic Coordinator of this site? Confirm its status | Waukee | United States | Unknown status |
| Methodist West Hospital Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Marshfield Medical Center - Weston Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.