Actively Recruiting
Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-07
47
Participants Needed
54
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary CNS diffuse large B-cell lymphoma by brain biopsy, cerebrospinal fluid, or vitreous fluid
- No prior organ transplantation
- No prior chemotherapy or radiation therapy for lymphoma
- No prior allogeneic stem cell transplantation
- Use of corticosteroids for disease control is allowed but must be tapered quickly
- Not pregnant or nursing with negative pregnancy test for females of childbearing potential
- Age 18 years or older
- Karnofsky performance scale of 40 or higher (50 or higher if over age 60 unless due to lymphoma)
- Absolute neutrophil count of at least 1,500/mm3
- Platelet count of at least 100,000/mm3
- Creatinine clearance of at least 50 mL/min
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- AST and ALT less than or equal to 2.5 times the upper limit of normal
- No evidence of non-Hodgkin's lymphoma outside the CNS
- No history of non-Hodgkin's lymphoma
- No history of autoimmune disorders that could affect vital organs or require immune suppressive treatment
- Patients with certain controlled conditions like vitiligo, type I diabetes, hypothyroidism, or psoriasis treated with topical medication are eligible
- Use of topical, ocular, inhalational, or low-dose corticosteroids allowed
- No prior or concurrent malignancies except certain cured skin or uterine cancers
- No untreated hepatitis B, hepatitis C, or HIV infections
- No history of HIV infection with EBV-related primary CNS lymphoma
- Ability to tolerate anticoagulation therapy
- No other investigational agents being used
- No severe allergic reactions to monoclonal antibodies or similar drugs
- Certain medications must be stopped 48 hours before methotrexate administration
You will not qualify if you...
- Prior organ transplantation
- Prior chemotherapy or radiation therapy for lymphoma
- Prior allogeneic stem cell transplantation
- Pregnant or nursing females
- Karnofsky performance scale below 40 (or below 50 for patients over 60 unless due to lymphoma)
- Absolute neutrophil count less than 1,500/mm3
- Platelet count less than 100,000/mm3
- Creatinine clearance below 50 mL/min
- Total bilirubin above 1.5 times the upper limit of normal
- AST or ALT above 2.5 times the upper limit of normal
- Evidence of non-Hodgkin's lymphoma outside the CNS
- History of non-Hodgkin's lymphoma
- Active autoimmune disorders requiring systemic immune suppressive treatment
- Active or acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or abdominal carcinomatosis
- Untreated hepatitis B, hepatitis C, or HIV infection with detectable viral load or low CD4+ count
- History of HIV infection with EBV-related primary CNS lymphoma
- Inability to tolerate anticoagulation therapy
- Use of other investigational agents
- History of severe hypersensitivity to monoclonal antibodies or related compounds
- Use of certain medications within 48 hours before methotrexate administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 54 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
UCSF Medical Center-Parnassus
San Francisco, California, United States, 94143
Actively Recruiting
3
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
4
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
5
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
6
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
7
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, United States, 33181
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
9
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
10
Saint Anthony Regional Hospital
Carroll, Iowa, United States, 51401
Actively Recruiting
11
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
12
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
13
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
14
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Actively Recruiting
15
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
16
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
17
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Suspended
18
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, United States, 50501
Suspended
19
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
20
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
Suspended
21
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States, 70805
Active, Not Recruiting
22
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States, 70808
Active, Not Recruiting
23
MaineHealth Maine Medical Center - Portland
Portland, Maine, United States, 04102
Actively Recruiting
24
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, United States, 04074
Actively Recruiting
25
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, United States, 04106
Actively Recruiting
26
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Active, Not Recruiting
27
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States, 48162
Active, Not Recruiting
28
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
29
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
30
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
31
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
32
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
33
Overlook Hospital
Summit, New Jersey, United States, 07902
Actively Recruiting
34
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States, 11042
Actively Recruiting
35
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
36
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
37
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
38
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Active, Not Recruiting
39
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
40
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
41
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Active, Not Recruiting
42
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
43
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
44
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
45
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Suspended
46
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Active, Not Recruiting
47
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
48
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
49
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
50
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
51
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States, 54548
Actively Recruiting
52
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Actively Recruiting
53
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
54
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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