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New treatment option for Relapsed Large B-cell Lymphoma
Official title Outpatient Epcoritamab as 2L in NTE R/R DLBCL
ClinicalTrials.gov ID: NCT06811272
What this study is testing
What is Epcoritamab?
Epcoritamab is an investigational medicine, being studied as a potential treatment for relapsed large b-cell lymphoma.
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 measure the efficacy of the study drug, epcoritamab, in participants with relapsed/refractory large B-cell lymphoma.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
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
- Participants must have large B-cell lymphoma of one of the following histologic subtypes by WHO criteria:
- Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS)
- High grade B-cell lymphoma (HGBCL) with rearrangements of MYC and BCL2 and/or BCL6
- HGBCL NOS
- EBV+ DLBCL
You likely can't join if
- Participant must not have used an investigational drug or approved systemic lymphoma therapy within 28 days preceding the first dose of study drug...
- Participants must not have received prior CD20/CD3 bispecific antibody.
- Participants must not have received prior autologous or allogeneic stem cell transplant.
- Participants must not have received prior anti-CD19 CAR T-cell therapy.
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the...
- Participants must not have known central nervous system involvement by lymphoma.
See the full eligibility criteria
Who can join
- Participants must have large B-cell lymphoma of one of the following histologic subtypes by WHO criteria:
- Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS)
- High grade B-cell lymphoma (HGBCL) with rearrangements of MYC and BCL2 and/or BCL6
- HGBCL NOS
- EBV+ DLBCL
- Primary mediastinal B-cell lymphoma
- T-cell/histiocyte rich LBCL
- Grade 3B follicular lymphoma
- Large B-cell lymphoma transformed from underlying indolent NHL
- PET measurable disease per Lugano criteria.
- Relapsed or refractory disease treated with 1 prior systemic antineoplastic line of therapy that includes an anti-CD20 monoclonal antibody and an anthracycline or an alkylating agent. Patients who have received more...
- Age ≥18 years.
- ECOG performance status 0-2.
- Not a candidate for high dose chemotherapy and autologous stem cell transplant per the treating investigator, or patient refusal of high dose chemotherapy and autologous transplant.
- Participants must meet the following organ and marrow function as defined below:
- absolute neutrophil count ≥1,000/mcL (Growth factor support is permitted)
- platelets ≥75,000/mcL (\>50,000 in the presence of bone marrow involvement or splenomegaly; platelet transfusions are permitted)
- Hemoglobin ≥8 g/dL (\>7 g/dL in the presence of bone marrow involvement; blood transfusions are permitted)
- Participants must have adequate organ function as defined below (unless abnormalities are considered related to target organ involvement or compression by lymphoma):
- total bilirubin ≤ 1.5x institutional upper limit of normal (ULN) (Isolated bilirubin ≤3.0x ULN is acceptable if considered secondary to Gilbert's syndrome)
- AST(SGOT) and ALT(SGPT) ≤3.0x institutional ULN
- Creatinine clearance ≥45 mL/min eGFR (Cockcroft-Gault or MDRD equation)
- PT within institutional normal range (unless on anticoagulation expected to affect PT, in which case PT cut off does not apply)
- PTT within institutional normal range (unless on anticoagulation expected to affect PTT, in which case PTT cut off does not apply)
- Ability to remain within 60 minutes of the administration site for 24 hours following cycle 1 day 15 dose of study drug.
- The effects of epcoritamab on the developing human fetus are unknown. Women of child-bearing potential must agree to use adequate contraception starting with the first dose of study drug, for the duration of study...
- Male Partner Sterilization: When the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate.
- Use of a combination of any two of the following (one from "a" and one from "b"):
- Placement of an intrauterine device (IUD) or intrauterine system or established use of oral, injected, or implanted hormonal methods of contraception
- Barrier methods of contraception: Male Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- True abstinence, defined as refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject.
- Nonchildbearing potential is defined as follows:
- ≥45 years of age and has not had menses for at least 12 consecutive months.
- people who have been amenorrhoeic for \<1 year must have, on at least two occasions prior to first dose of study drug, a follicle stimulating hormone value greater than 40 IU/L; historical follicle stimulating hormone...
- Post-bilateral oophorectomy (with or without hysterectomy) or post-tubal ligation at least six weeks prior to first dose of study drug. Documented oophorectomy must be confirmed with medical records of the actual...
- Women of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test at screening.
- Fertile men, defined as all males physiologically capable of conceiving offspring who are sexually active with a female partner of childbearing potential, must agree to use adequate contraception starting with the first...
- Ability to understand and the willingness to sign a written informed consent document by the participant or a legally authorized representative.
What rules you out
- Participant must not have used an investigational drug or approved systemic lymphoma therapy within 28 days preceding the first dose of study drug. Steroids for lymphoma disease control are permitted but must be stopped...
- Participants must not have received prior CD20/CD3 bispecific antibody.
- Participants must not have received prior autologous or allogeneic stem cell transplant.
- Participants must not have received prior anti-CD19 CAR T-cell therapy.
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia. At the discretion of the overall PI, participants with...
- Participants must not have known central nervous system involvement by lymphoma.
- Participants must not have a current life-threatening illness, medical condition, or organ system dysfunction (other than the disease under study) which, in the Investigator's opinion, could compromise the subject's...
- Participants must not have an uncontrolled active infection. Localized fungal infection of skin or nails are permitted.
- Participants must not have active uncontrolled autoimmune disease. Autoimmune disease under control with chronic systemic corticosteroids at a dose of 10 mg/day of prednisone or less, or equivalent corticosteroid, are...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab. A history of an infusion reaction to CD20-directed therapy is not considered an allergic reaction.
- Women who are pregnant are excluded from this study because it is unknown if epcoritamab can cause embryo-fetal harm when administered to a pregnant woman. Because there is an unknown but potential risk for adverse...
- Participant must not have active uncontrolled HIV infection. Participants with HIV are eligible if disease is adequately controlled on an antiretroviral regimen that is in accordance with the current international AIDS...
- Participant must not have active hepatitis B infection. Participants with positive HBV core antibody or HBV surface antigen at screening are eligible if HBV viral load is negative by PCR and they are on appropriate...
- Participant must not have active hepatitis C infection. Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained...
- Subject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection or has had recent known exposure to someone with...
- Participants must not have received a live virus vaccine within 28 days of first dose of study drug.
- Participants must not have any known past or current malignancy other than inclusion diagnosis, except for:
- Cervical carcinoma of Stage 1B or less.
- Non-invasive basal cell or squamous cell skin carcinoma.
- Non-invasive, superficial bladder cancer.
- Prostate cancer with a current PSA level \<0.1 ng/mL.
- Any curable cancer with a complete response (CR) of \>2 years duration
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Newton, 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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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; Newton, 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.