This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete). Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R/R primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles. Part C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R/R PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R/R PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.
Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
This trial is no longer recruiting — here are similar active trials
Matched by cancer type/biomarker, currently recruiting.
Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * How the study drug affects quality of life and ability to complete routine daily activities.
The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie chłoniak pierwotny rozlany z dużych komórek B w OUN (z biopsji lub płynu mózgowo-rdzeniowego/oka).
- •Brak wcześniejszej chemioterapii lub radioterapii z powodu chłoniaka.
- •Brak wcześniejszego przeszczepu narządów lub komórek macierzystych.
- •Kobiety niebędące w ciąży ani niekarmiące (wymagany test ciążowy).
- •Wiek co najmniej 18 lat.
- •Ogólny stan zdrowia pozwalający na leczenie (Karnofsky > 40).
- •Odpowiednie wyniki badań krwi (białe krwinki, płytki krwi).
- •Prawidłowe wyniki badań nerek i wątroby.
✗ Disqualifies
- •Chłoniak poza ośrodkowym układem nerwowym.
- •Choroby autoimmunologiczne (mogące wpływać na narządy lub wymagać leczenia immunosupresyjnego).
- •Wcześniejsza chemioterapia lub radioterapia w leczeniu chłoniaka.
- •Wcześniejszy przeszczep narządów lub komórek macierzystych.
- •Ciąża lub karmienie piersią.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 4, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (56)
Cedars-Sinai Medical Center
Los Angeles, United States
UCSF Medical Center-Parnassus
San Francisco, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, United States
UM Sylvester Comprehensive Cancer Center at Doral
Doral, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, United States
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, United States
Saint Anthony Regional Hospital
Carroll, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, United States
Iowa Methodist Medical Center
Des Moines, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, United States
Broadlawns Medical Center
Des Moines, United States
Mercy Medical Center - Des Moines
Des Moines, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, United States
Iowa Lutheran Hospital
Des Moines, United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, United States
Methodist West Hospital
West Des Moines, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, United States
Our Lady of the Lake Physician Group
Baton Rouge, United States
MaineHealth Maine Medical Center - Portland
Portland, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, United States
Hickman Cancer Center
Adrian, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, United States
Washington University School of Medicine
St Louis, United States
Siteman Cancer Center-South County
St Louis, United States
Siteman Cancer Center at Christian Hospital
St Louis, United States
Overlook Hospital
Summit, United States
Northwell Health/Center for Advanced Medicine
Lake Success, United States
North Shore University Hospital
Manhasset, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, United States
NYP/Weill Cornell Medical Center
New York, United States
State University of New York Upstate Medical University
Syracuse, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, United States
Ohio State University Comprehensive Cancer Center
Columbus, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, United States
University of Oklahoma Health Sciences Center
Oklahoma City, United States
Rhode Island Hospital
Providence, United States
Medical University of South Carolina
Charleston, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, United States
West Virginia University Healthcare
Morgantown, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, United States
Gundersen Lutheran Medical Center
La Crosse, United States
Marshfield Medical Center-Marshfield
Marshfield, United States
Marshfield Medical Center - Minocqua
Minocqua, United States
Marshfield Medical Center-Rice Lake
Rice Lake, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, United States
Marshfield Medical Center - Weston
Weston, United States
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.
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