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New treatment option for Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
Official title Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
ClinicalTrials.gov ID: NCT04609046
What this study is testing
What is Lenalidomide?
Lenalidomide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for primary diffuse large b-cell lymphoma of the central nervous system.
Also referred to as CC 5013, CC-5013.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Miami, Florida, United States
- North Miami, Florida, United States
- Plantation, Florida, United States
- Ankeny, Iowa, United States
- Carroll, Iowa, United States
- Clive, Iowa, United States
- Des Moines, Iowa, United States
- Fort Dodge, Iowa, United States
- Iowa City, Iowa, United States
- Waukee, Iowa, United States
- West Des Moines, Iowa, United States
- Baton Rouge, Louisiana, United States
- Portland, Maine, United States
- Scarborough, Maine, United States
- South Portland, Maine, United States
- Adrian, Michigan, United States
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Coral Gables, Florida, United States; Deerfield Beach, Florida, United States; Miami, Florida, United States; North Miami, Florida, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.