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New treatment option for Follicular Lymphoma
Official title Odronextamab in Low Tumor Volume Advanced FL
ClinicalTrials.gov ID: NCT07128641
What this study is testing
What is Odronextamab?
Odronextamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for follicular lymphoma.
Also referred to as REGN1979.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of...
- Lymph node biopsy obtained in the previous 6 months
- people 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
You likely can't join 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)
See the full eligibility criteria
Who can join
- 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
- people 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...
- 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...
- stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition...
- 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...
- sexual abstinence†, ‡.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal...
- WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral...
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the assigned study treatments. The reliability of...
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Female...
- WOCBP must have negative serum pregnancy test at screening.
- Sexually active adult men must agree to use the following forms of medically acceptable birth control: consistent use of a condom OR vasectomy with medical assessment of surgical success, prior to initial dose, during...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Known current alcohol or drug abuse, psychiatric illness, or unstable social situation that is likely to limit compliance with study requirements
- Allergy/hypersensitivity:
- Known hypersensitivity to both allopurinol and rasburicase
- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biological components
- Exposure to a live or a live attenuated vaccine within 4 weeks
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.