Odronextamab in Low Tumor Volume Advanced FL

Recruiting now · Phase 2

Conditions studied: Follicular Lymphoma, Lymphoma

In brief

The purpose of this study is to evaluate the safety and effectiveness of treating previously untreated Follicular Lymphoma (FL) with odronextamab. The name of the study drug in this research study is: -Odronextamab (a type of monoclonal antibody)

Key facts

Study ID: NCT07128641
Run by: Gottfried von Keudell, MD PhD
People needed: 35
Starts: 2025-09-08
Expected to finish: 2028-01-02
Last updated by the study team: 2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of diagnosis. All degrees of CD20 positivity will be accepted.
Lymph node biopsy obtained in the previous 6 months
Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm
Age ≥18 years
ECOG performance status > 2
Life expectancy of > 2 years
Participants must meet the following organ and marrow function as defined below:
Absolute neutrophil count ≥1000 cells/mcl
Platelets ≥100,000 cells/mcl
Hemoglobin ≥ 10 g/dL
Adequate organ function, as documented by:
Cardiac ejection fraction >40% by echocardiogram or multi-gated acquisition (MUGA) scan
Total bilirubin ≤1.5 × upper limit of normal (ULN) (≤3 × ULN if attributed to lymphoma infiltration of liver)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if attributed to lymphoma infiltration of liver)
Alkaline phosphatase (ALP) ≤2.5 × ULN (≤5 × ULN if attributed to lymphoma infiltration of liver)
Calculated creatinine clearance by Cockcroft Gault formula ≥40 mL/min
NOTE: Irrespective of the presence of lymphoma infiltration of the liver, a participant with an AST >3 × ULN and/or ALT >3 × ULN concurrent with a total bilirubin >1.5 × ULN will be excluded.
NOTE: Participants with known Gilbert syndrome will be excluded if the total bilirubin value is >4 × ULN.
NOTE: Participants with a calculated creatinine clearance
Patients with hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible but will be required to receive appropriate antiviral prophylaxis as described in Section 5.2. Patients with Hepatitis C antibody must have undetectable viral load.
Women of childbearing potential (WOCBP)* must agree to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose of odronextamab. Egg donation is prohibited during the study and for 6 months after the last dose of the assigned study treatment. Highly effective contraceptive measures include:
stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening.
intrauterine device (IUD); intrauterine hormone-releasing system (IUS)
bilateral tubal ligation/occlusion
vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure)

You may not qualify if…

Participants must not meet any GELF Criteria for high tumor volume, or other circumstances for which immediate therapy would be indicated
Any nodal or extranodal tumor mass >7 cm diameter
Involvement of at least 3 nodal sites, each with diameter >3 cm
Presence of any systemic or B symptoms for greater than 2 weeks (fever, night sweats, or weight loss)
Splenic enlargement with inferior margin below the umbilical line
Compression syndrome (ureteral, orbital, gastrointestinal)
Pleural or peritoneal serous effusion (irrespective of cell content)
Leukemic phase (>5.0 x10⁹/L circulating malignant cells)
Cytopenia (granulocyte count < 1.0x10⁹/L and/or platelets < 100x10⁹/L)
Infections:
Evidence of any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other) at study enrollment or within 2 weeks of study enrollment, if requiring ongoing treatment and/or has the potential to cause disseminated disease or severe infection upon immunosuppression. There should be evidence that the infection has cleared or is well controlled by start of study therapy.
Active symptomatic COVID-19 infection. Note, patients with prolonged PCR positivity (>2 weeks after initial diagnosis) may be allowed to participate following discussion with the PI
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) NOTE: Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 cells/μL either spontaneously or on a stable antiviral regimen) are permitted NOTE: Participants who are hepatitis B surface antigen positive or who are hepatitis B core antibody positive should undergo evaluation by a specialist and be considered to have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) before they are permitted onto study NOTE: Participants who are HCV antibody positive who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted
Another active malignancy (aside from B-cell NHL) in the past 2 years, with the following exceptions: non-melanoma skin cancer that has undergone potentially curative therapy, in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
Limited-stage follicular lymphoma (stage I and limited stage II) with a possibility of treatment with a curative intent using radiotherapy
Duodenal follicular lymphoma
Follicular lymphoma with spontaneous regression prior to treatment initiation
Patients who have had any prior systemic therapy for lymphoma, including rituximab and/or tazemetostat
Patients who have had prior radiation therapy, with the following exception: Low dose radiotherapy RT (2x2Gy, or 4Gy x 1) is allowed but must be completed at least 12 weeks prior to treatment on this study; patients must meet criteria for measurable/assessable disease as outlined above after completion of RT, and have a nodal evaluable disease outside the radiation area
Uncontrolled underlying cardiac conditions including but not limited to: congestive heart failure grade III or IV (by NYHA) or EF < 45%, unstable angina pectoris, acute myocardial infarction < 6 months, cardiac arrhythmia
History of uncontrolled neurologic condition including but not limited to: seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis
Immunosuppressive therapy for non-lymphoma-related indication within 28 days of initiation of treatment, including systemic corticosteroids 10 mg/day or greater prednisone-equivalent
Patients with known or suspected CNS involvement or leptomeningeal disease are excluded
History of neurodegenerative condition or CNS movement disorder. Patients with a history seizure within 12 months prior to study enrollment are excluded.
Pregnant women or participants unwilling to adhere to institutional guidelines for highly effective contraception during odronextamab treatment and for 12 months after the last dose are excluded from this study because of documented (rituximab) and unknown risks of the treatment effect on fetal development.

Where it is running

Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.