BridgeMD
New treatment option for Lymphoma
Official title Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy
ClinicalTrials.gov ID: NCT06510361
What this study is testing
What is Epcoritamab?
Epcoritamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for lymphoma.
Also referred to as DuoBody-CD3xCD20, GEN3013.
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
- This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment. The name of the study drug in this research study is: -Epcoritamab (a type of 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...
- people must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm and short axis \>1.0 cm and...
- Stage III/IV at initial diagnosis
- 1 prior line (at least 3 cycles) of systemic "upfront" or first-line therapy consisting of anti-CD20 antibody (e.g. obinutuzumab or rituximab)...
- people need to have achieved a partial response or stable disease as best response following upfront treatment. people with progressive disease will...
You likely can't join if
- Use of investigational agents incorporated into prior induction therapy
- Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment
- Uncontrolled underlying cardiac conditions including but not limited to congestive heart failure grade III or IV (by NYHA) or EF \<45%, unstable...
- History of uncontrolled neurologic condition including but not limited to seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis
- EF \ 89%
- Immunosuppressive therapy for non-lymphoma-related indication within 28 days (or for lymphoma within 10 days) of initiation of treatment, including...
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. Composite...
- people must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm and short axis \>1.0 cm and Deauville ≥ 4 seen on baseline PET/CT
- Stage III/IV at initial diagnosis
- 1 prior line (at least 3 cycles) of systemic "upfront" or first-line therapy consisting of anti-CD20 antibody (e.g. obinutuzumab or rituximab) combined with chemotherapy (e.g. bendamustine, CHOP, CVP, or lenalidomide)...
- people need to have achieved a partial response or stable disease as best response following upfront treatment. people with progressive disease will be excluded.
- people must have completed all prior anti-lymphoma therapy at least 4 weeks (28 days) prior to start of epcoritamab.
- Age ≥18 years.
- 3.1.7 Age ≥18 years.
- ECOG performance status ≤ 2
- Life expectancy of greater than 2 years
- Participants must meet the following organ and marrow function as defined below:
- Absolute neutrophil count ≥1000 cells/mcl (G-CSF allowed if marrow involved with disease)
- Platelets ≥75,000 cells/mcl (transfusion allowed if marrow involved)
- Hemoglobin ≥ 8 g/dL (transfusion allowed if marrow involved)
- Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). In patients with suspected/known Gilbert's disease total bilirubin up to 3x ULN will be allowed
- AST(SGOT)/ALT(SGPT) ≤3× institutional ULN unless suspected/known involvement by follicular lymphoma
- Creatinine ≤ institutional ULN OR creatinine clearance \> 45 ml/min (by Cockcroft-Gault estimate or 24-hr creatinine clearance measurement)
- 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 5.4. Patients with...
- Participants with a history of prior malignancy will be eligible if all treatment of that malignancy was completed at least 2 years prior to enrollment to this study, the treatment was considered "curable-intent", and...
- Resolution of toxicities from prior therapy to baseline or grade ≤1 (with the exception of grade 2 peripheral neuropathy or any grade alopecia)
- Ability to understand and the willingness to sign a written informed consent document.
- Females of childbearing potential must agree to practice a highly effective method of birth control (as defined by the EU Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth...
- Established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
- Male partner sterilization (the vasectomized partner should be the sole partner for that patient)
- True abstinence (when this is in line with the preferred and usual lifestyle of the patient)
- Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of epcoritamab. Men must also not donate sperm during the...
- A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (i.e. use of condom) during the trial and for 12 months after receiving the last dose of...
What rules you out
- Use of investigational agents incorporated into prior induction therapy
- Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment
- 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
- EF \ 89%
- Immunosuppressive therapy for non-lymphoma-related indication within 28 days (or for lymphoma within 10 days) of initiation of treatment, including systemic corticosteroids 10 mg/day or greater of prednisone or...
- Patients with known or suspected CNS involvement or leptomeningeal disease are excluded given concern for potentially increased risk of neurologic toxicity with epcoritamab. Patients with history of CNS malignancy from...
- Pregnant or breastfeeding women or participants unwilling to adhere to institutional guidelines for highly effective contraception for the duration of the therapy are excluded. This is because of the unknown but...
- Premenarchal
- Postmenopausal (\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level \>40 IU/L or mIU/mL)
- Permanently sterilized (e.g., bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy) Note: If the...
- Known current alcohol or drug abuse, psychiatric illness, or unstable social situation that is likely to limit compliance with study requirements
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab
- Exposure to a live or a live attenuated vaccine within 4 weeks
- Patients with HIV will be excluded
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Boston, Massachusetts, United States
- New York, New York, 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 Stanford, California, United States; Boston, Massachusetts, United States; New York, New York, 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.