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Clinical Trials in Poland / NCT03888105
Active, not recruiting Phase 2

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

NCT03888105 · tracked via the Priya Life Science Poland tracker
Phase
Phase 2
Started
2019-11-13
Last updated
2026-07-31

Condition(s) studied

B-cell Non-Hodgkin Lymphoma (B-NHL)

Investigational drug(s) / intervention(s)

Odronextamab →

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)

Trial sites (119)

FacilityCityRegionStatus
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.

More Regeneron Pharmaceuticals trials in Poland

Official registry record

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.

View NCT03888105 on ClinicalTrials.gov ↗ ← All trials in Poland