A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies
Odronextamab: Administered by intravenous (IV) infusion
Study summary
This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL).
The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab.
The study is looking at several other research questions, including:
* To see if odronextamab works to destroy cancer cells
* Side effects that may be experienced by people taking odronextamab
* How odronextamab works in the body
* How much odronextamab is present in the blood
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
1. For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017)
2. Disease-specific cohorts:
Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
* FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, as defined in the protocol
* DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
* MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
* MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy
* Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
3. Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Adequate bone marrow, hepatic, and renal function as defined in the protocol
Key Exclusion Criteria:
1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI)
2. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter
3. History of allogeneic stem cell transplantation, up to 12 months prior to first administration of study drug. The presence of acute or chronic graft-versus host disease (GVHD) will also be an exclusion
4. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
5. History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
6. Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent
7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
8. Known hypersensitivity to both allopurinol and rasburicase
9. Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Primary outcome measure(s)
Objective Response Rate (ORR), as assessed by independent central review — Up to 52 weeks of study treatment FL grade 1-3a/MZL
ORR, as assessed by independent central review — Up to 36 weeks of study treatment DLBCL/MCL/Other B-NHL
Trial sites (119)
Facility
City
Region
Status
Rush University Medical Center
Chicago
Illinois
University of Iowa
Iowa City
Iowa
Norton Cancer Institute
Louisville
Kentucky
Tufts Medical Center
Boston
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Mayo Clinic - Rochester
Rochester
Minnesota
John Theurer Cancer Center at Hackensack UMC
Hackensack
New Jersey
Weill Cornell Medical College New York Presbyterian Hospital
New York
New York
Stony Brook University Hospital
Stony Brook
New York
Wake Forest Baptist Medical Center
Winston-Salem
North Carolina
Cleveland Clinic Foundation
Cleveland
Ohio
Stephenson Cancer Center
Oklahoma City
Oklahoma
Harold C. Simmons Comprehensive Cancer Center
Dallas
Texas
Border Medical Oncology
East Albury
New South Wales
Northern NSW Local Health District The Tweed Hospital
Tweed Heads
South Wales
Epworth Hospital
East Melbourne
Victoria
North Building
Frankston
Victoria
Andrew Love Cancer Centre
Geelong
Victoria
Olivia Newton John Cancer Wellness & Research Centre
Heidelberg
Victoria
Royal Perth Hospital
Perth
Western Australia
Cross Cancer Institute
Edmonton
Alberta
QEII Health Science Centre - Halifax location
Halifax
Nova Scotia
Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)
Beijing
Beijing Municipality
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Institute of Hematology & Blood Diseases Hospital
Tianjin
Beijing Municipality
Second Affiliated Hospital - Xinqiao Hospital
Chongqing
Chongqing Municipality
Sun Yat-Sen University Cancer Center - Cancer Prevention and Treatment Center, Sun Yat-sen University
Guangzhou
Guangdong
The Affiliated Tumor Hospital
Harbin
Heilongjiang
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan
Hubei
The First Affiliated Hospital - Soochow University
Suzhou
Jiangsu
The First Bethune Hospital
Changchun
Jilin
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an
Shaanxi
Shanhai Cancer Center
Shanghai
Shanghai Municipality
West China Hospital
Chengdu
Sichuan
Tianjin Medical University Cancer Institute
Tianjin
Tianjin Municipality
The First Hospital affiliated to the Medical School of Zhejiang University
Hangzhou
Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Peking University - Third Hospital
Beijing
China
Hopital Haut-Leveque
Pessac
Aquitaine
+ 79 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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