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Tests treatment safety and results for Large Cell Lymphoma, Diffuse
Official title Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT05852717
What this study is testing
What is GDP?
GDP is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for large cell lymphoma, diffuse.
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
- Subjects with relapsed large cell lymphoma will receive 3 cycles of combination therapy consisting of GDP and epcoritamab. Each cycle will last 21 days.
- 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
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be...
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-2 within 28 days prior to registration.
- Histologically confirmed CD20+ relapsed large cell lymphoma according to the 5th edition of the WHO classification of the hematolymphoid tumors and...
- Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (\>) 1.5...
You likely can't join if
- Previous treatment with gemcitabine, cisplatin, and epcoritamab or other bispecific T-cell engager antibody (BsAB) such as glofitamab, mosunetuzumab...
- Known active central nervous system or meningeal involvement by large cell lymphoma at time of screening. Patients diagnosed with CNS disease who...
- Contraindication to any drug contained in the combination therapy regimen (GDP).
- Known hypersensitivity or allergic reaction to epcoritamab or its' excipients.
- Use of any standard or experimental anti-large cell lymphoma therapy (including nonpalliative radiation, chemotherapy, immunotherapy...
- Major surgery \< 14 days of Cycle 1 Day 1.
See the full eligibility criteria
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-2 within 28 days prior to registration.
- Histologically confirmed CD20+ relapsed large cell lymphoma according to the 5th edition of the WHO classification of the hematolymphoid tumors and the 2022 international consensus classification of mature lymphoid...
- Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \>1 cm (per the Lugano Criteria...
- Have received at least 1 prior line of systemic therapy for the treatment of large cell lymphoma. NOTE: Prior radiation therapy or systemic corticosteroids will not be considered a line of therapy.
- Patients must be deemed eligible to proceed with stem cell transplantation (autologous or allogeneic) or CAR T-cell therapy per treating physician discretion. Prior autologous stem cell transplantation or CAR T-cell...
- Must have had relapsed or refractory disease following standard frontline chemotherapy. Refractory disease is defined as large cell lymphoma not achieving complete remission, progressing, or relapsing within 6 months...
- Archival tissue obtained within 2 years of signing consent is required if available and will be identified at screening and shipped prior to Cycle 2 Day 1. If archival tissue is not available, but the subject is...
- Demonstrate adequate organ function. All screening labs to be obtained within 21 days prior to registration. \ Patients with bone marrow involvement will be eligible to participate in the study but must meet hematologic...
- Life expectancy of ≥ 6 months, as determined by the enrolling physician or protocol designee.
- Females people of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study treatment. If a urine test is done and it is positice ir cannot be confirmed as negative, a...
- Female people of childbearing potential and male people must be willing to abstain from penile-vaginal intercourse or to use an effective method(s) of contraception.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
- Previous treatment with gemcitabine, cisplatin, and epcoritamab or other bispecific T-cell engager antibody (BsAB) such as glofitamab, mosunetuzumab, or odronextamab.
- Known active central nervous system or meningeal involvement by large cell lymphoma at time of screening. Patients diagnosed with CNS disease who achieved and maintained CNS CR at the time of relapse are eligible...
- Contraindication to any drug contained in the combination therapy regimen (GDP).
- Known hypersensitivity or allergic reaction to epcoritamab or its' excipients.
- Use of any standard or experimental anti-large cell lymphoma therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \< 14 days prior to C1D1. NOTE...
- Major surgery \< 14 days of Cycle 1 Day 1.
- Neuropathy Grade ≥ 2 (CTCAE v.5.0).
- Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, non-invasive superficial bladder cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, localized...
- Active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring systemic treatment within 7 days prior to the first dose of study treatment...
- Active HIV infection. NOTE: Testing for HIV antibody is required at the time of screening. Those with positive HIV antibody will require HIV viral load by PCR testing. Patients with detectable viral load will not be...
- Testing for hepatitis B (HBV) and hepatitis C virus (HCV) is required at screening. Hepatitis B testing will consist of Hepatitis B surface Antigen (HBsAg), Hepatitis B Core Antibody (HBcAb) and Hepatitis Surface...
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety, or being compliant with the study procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Detroit, Michigan, United States
- Dallas, Texas, United States
- Charlottesville, Virginia, 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 Indianapolis, Indiana, United States; Detroit, Michigan, United States; Dallas, Texas, United States; Charlottesville, Virginia, 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.