Is NCT06784726 recruiting in Seattle, WA?

Yes, NCT06784726 is currently recruiting participants at its Seattle, WA location. This recurrent diffuse large b-cell lymphoma clinical trial is actively enrolling qualified participants.

Is participation in this Seattle clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Recurrent Diffuse Large B-Cell Lymphoma Clinical Trial in Seattle, WA

Q: How do I join the recurrent diffuse large b-cell lymphoma clinical trial in Seattle?

To join this clinical trial in Seattle, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Recurrent Diffuse Large B-Cell Lymphoma Study in Seattle

This phase II trial tests the effectiveness of odronextamab given before chimeric antigen receptor T (CAR-T) cell therapy (bridging therapy) in patients with large B-cell lymphomas that have come back after a period of improvement (relapsed) or that have not responded to previous treatment (refractory). Odronextamab is a bispecific antibody that can bind to two different antigens at the same time. Odronextamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Bridging therapy has been used to maintain disease control and to increase the chance of successful receipt of CAR-T cell therapy. However, bridging therapy is typically given after leukapheresis, which does not help prevent disease progression between the decision for CAR-T cell therapy and leukapheresis. Giving odronextamab as bridging therapy before leukapheresis may delay disease progression to allow leukapheresis and increase the likelihood of successful CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphomas.

Sponsor: University of Washington

Who Can Participate

Inclusion Criteria

Histologically confirmed large B cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, DLBCL arising from indolent lymphoma, follicular lymphoma (FL) grade 3B

Measurable disease, defined as at least one measurable lesion ≥ 15 mm on PET, CT, or magnetic resonance imaging (MRI) within one month of screening, according to the International Working Group consensus response evaluation criteria in lymphoma

Prior frontline therapy for large B cell lymphoma must have failed the patient, and criteria must be met for receiving commercial axicabtagene ciloleucel (axi-cel), lisocabtagene maraleucel (liso-cel), or tisagenlecleucel (tisa-cel) per Food and Drug Administration (FDA) label

Age ≥ 18 years

Capable of understanding and providing a written informed consent

Prior treatment with an anti-CD20 antibody therapy

Eastern Cooperative Oncology Group performance status of 0-1; we allow enrollment of patients with a performance status of 2 if it is attributed to lymphoma per discretion of the treating physician or principal investigator (PI)

Creatinine clearance ≥ 45 mL/min calculated by Cockcroft-Gault equation

Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome

Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x the ULN

Adequate pulmonary function, defined as ≤ grade 1 dyspnea and oxygen saturation (SpO2) ≥ 92% on room air

Adequate cardiac function, defined as left ventricular ejection fraction ≥ 50% and without evidence for pericardial effusion

Platelet count ≥ 75 x 10\^9 /L

Hemoglobin (Hg) level ≥ 9 g/dL

Absolute neutrophil count (ANC) ≥ 1 x 10\^9 /L

Patients with bone marrow involvement or splenic sequestration: Platelet count ≥ 25 x 10\^9 /L

Patients with bone marrow involvement or splenic sequestration: Hg ≥ 7.0 g/dL

Patients with bone marrow involvement or splenic sequestration: ANC ≥ 0.5 x 10\^9 /L

Negative serum pregnancy test within 2 days of initiating odronextamab for women of childbearing potential (WOCBP), defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year

Fertile male and WOCBP patients must be willing to use highly effective contraceptive methods from study recruitment to at least 6 months after the CAR T-cell infusion

Patients must not provide egg or sperm donation until at least 6 months after the completion of the last dose of Odron

Exclusion Criteria

Detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases. Patients with a history of secondary central nervous system (CNS) lymphoma may be eligible provided that there has been no evidence of CNS disease from lymphoma for at least 3 months at the time of screening

History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement

Standard anti-neoplastic chemotherapy (non-biologic) within 5-times the half-life or within 2 weeks, whichever is shorter, prior to first administration of study drug

Standard radiotherapy within 2 weeks of first administration of study drug

Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy, unless all the following are met: disease responded to prior bispecific therapy (CR or PR per Lugano criteria) and did not experience disease progression within 12 months of the last dose of prior bispecific therapy, and the tumor must still express CD20 (CD20 examination per standard of care \[SOC\])

Allogeneic stem cell transplantation

Any CAR-T cell therapy

Patients may not be receiving other investigational agents

Treatment with rituximab, alemtuzumab, or other investigational or commercial biologic agent within 2 weeks prior to first administration of study drug

Immunosuppressive therapy (other than biologic) within 2 weeks of first administration of study drug

Treatment with an investigational non-biologic agent within 2 weeks of first administration of study drug

History of allergic reactions attributed to compounds of similar chemical or biologic composition of study drug

History of hypersensitivity to any compound in the tetracycline antibiotics group

Concurrent active malignancy for which the patient is receiving systemic treatment, unless approved by PI

Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection

Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) and/or significant pulmonary disease (e.g., obstructive pulmonary disease and history of symptomatic bronchospasm)

Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent. A short course of corticosteroid for lymphoma disease control during screening is allowed

Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 400) or chronic infection with hepatitis B virus or hepatitis C virus. Patients with hepatitis B (hepatitis B surface antigen positive \[HepBsAg+\]) with controlled infection were permitted upon consultation with the physician managing the infection

Known hypersensitivity to both allopurinol and rasburicase

Pregnant or breast-feeding women

Administration of live vaccination within 28 days of first administration of study drug

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Seattle?

Yes, this clinical trial (NCT06784726) has an active research site in Seattle, WA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Diffuse Large B-Cell Lymphoma Treatment Options in Seattle, WA

If you're searching for recurrent diffuse large b-cell lymphoma treatment options in Seattle, WA, this clinical trial (NCT06784726) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Seattle research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced recurrent diffuse large b-cell lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent diffuse large b-cell lymphoma clinical trials near you to find additional studies recruiting in your area.

Recurrent Diffuse Large B-Cell Lymphoma Clinical Trial in Seattle, WA

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