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New treatment option for Large B-cell Lymphoma
Official title Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT06045247
What this study is testing
What is Prednisone?
Prednisone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- To learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.
- 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
- Patients must meet the following criteria for study entry:
- Age ≥18 years
- Histologically diagnosed
- Diffuse large B-cell lymphoma, not otherwise specified (NOS) or
- High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) or
You likely can't join if
- people will be ineligible for this study if they meet any of following criteria:
- Known central nervous system lymphoma or leptomeningeal disease
- Suspicious case with symptoms should be evaluated with brain MRI with or without Any prior history of other malignancy besides B-NHL, unless the...
- Adequately treated localized skin cancer without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's...
See the full eligibility criteria
Who can join
- Patients must meet the following criteria for study entry:
- Age ≥18 years
- Histologically diagnosed
- Diffuse large B-cell lymphoma, not otherwise specified (NOS) or
- High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) or
- T cell/histiocyte-rich large B-cell lymphoma
- Have no prior systemic treatment for current lymphoma
- Ineligible for anthracycline-based cytotoxic chemotherapy due to one or more of the following:
- Age ≥80
- Unfit/frail by simplified geriatric assessment4
- The link to calculate simplified geriatric assessment https://redcap.filinf.it/surveys/?s=89AFXML8AK Criteria Fit Unfit Frail ADL ≥ 5 \< 5 6 \< 6 IADL ≥ 6 \< 6 8 \< 8 CIRS-G 0 score = 3-4 ≤ 8 score = 2 ≥ 1 score = 3-4 8...
- Ejection fraction (EF) \<50% but ≥30%
- Needs to be asymptomatic or minimally symptomatic, New York Heart Association (NYHA) class 1 or 2
- Previous cardiotoxic cancer treatment with anthracycline
- Stage II bulky (\>7cm), III or IV disease
- Performance status ≤2 on the ECOG scale (PS ≤3 if attributed to lymphoma and improves to ≤2 by pre-phase treatment prior to enrollment)
- Bi-dimensionally measurable disease, with at least one nodal lesion ≥ 1.5 cm or one extra-nodal lesion \> 1 cm in longest diameter by CT, PET/CT, and/or MRI
- Patients must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥1.0 × 109/L\ --\ Growth factor permitted during screening
- Platelet count ≥75 × 109/L
- Total bilirubin ≤ 3 ULN, unless consistent with Gilbert's (ratio between total and direct bilirubin \> 5)
- AST and ALT ≤ 3x upper limit of normal (ULN)
- Alkaline phosphatase \< 2.5 ULN
- Creatinine clearance \>45 ml/min calculated by modified Cockcroft-Gault formula
- All people must
- Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 12 months following the last dose of study treatment.
- Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study. The investigator is responsible...
- Females must agree to abstain from breastfeeding during study participation and for at least 12 months after epcoritamab discontinuation.
- Females of childbearing potential (FCBP§) must:
- Have one negative pregnancy tests via serum or urine prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, prior to day 1 of each cycle, and after end of study...
- Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice. Otherwise, she must agree to use, and be able to comply with two forms of contraception: one...
- Male people must:
- A male subject who is sexually active with a female with reproductive potential must agree to use a barrier method of birth control, eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with...
What rules you out
- people will be ineligible for this study if they meet any of following criteria:
- Known central nervous system lymphoma or leptomeningeal disease
- Suspicious case with symptoms should be evaluated with brain MRI with or without Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 3 years and felt to be at low risk...
- Adequately treated localized skin cancer without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at undue risk.
- Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection...
- Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: people who are hepatitis B core antibody (anti-HBc) positive...
- History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.
- History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of...
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4...
- Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block, type II AV block, 3rd degree block, 12-lead ECG showing a baseline QTcF \>470 msec.
- History of stroke, seizure disorder or patients requiring antiepileptic therapy or intracranial hemorrhage within 6 months prior to study entry.
- Patients with more than mild pericardial effusion confirmed by ECHO.
- Lactating or pregnant people
- Administration of any investigational agent within 28 days of first dose of study drug.
- Patients who have undergone major surgery within 28 days or minor surgery within 3 days of first dose of study drug.
- Patients taking chronic corticosteroids for other diseases, unless administered at a dose equivalent to \ 20 mg daily (or equivalent) qualifies as immunosuppressive and thus is excluded for this use. Note...
- Life expectancy \< 6 months
- Neuropathy \> Grade 1
- Prior exposure to epcoritamab, independently from indication
- Patients who have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g...
- Patients who have a history of (non-infectious) pneumonitis that require steroids or has current pneumonitis.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, 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.