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New treatment option for Diffuse Large B-cell Lymphoma
Official title Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)
ClinicalTrials.gov ID: NCT06977711
What this study is testing
What is Loncastuximab?
Loncastuximab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for diffuse 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
- This study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants.
- Phase 1: an early, usually small safety study
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
- Men and women 18 years of age or older.
- Pathologically proven diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS). \- Patients with Diffuse large B-cell lymphoma/ high grade...
- No prior systemic therapy for lymphoma.
- Subject has provided informed consent.
- Subject is willing and able to comply with clinic visits and procedure outlined in the study protocol.
You likely can't join if
- Allergy or intolerance to roflumilast.
- Allergy or intolerance to loncastuximab
- Any active malignancy other than DLBCL
- Current participation in another treatment clinical study
- Prior allogeneic bone marrow transplant within 12 months of screening date.
- Prior autologous stem cell transplant within 6 months of screening date.
See the full eligibility criteria
- Men and women 18 years of age or older.
- Pathologically proven diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS). \- Patients with Diffuse large B-cell lymphoma/ high grade B-cell lymphoma with MYC (myelocytomatosis oncogene) and BCL2 (B-cell...
- No prior systemic therapy for lymphoma.
- Subject has provided informed consent.
- Subject is willing and able to comply with clinic visits and procedure outlined in the study protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy of ≥3 months.
- Ann Arbor stage II-IV
- National Comprehensive Cancer Network - International Prognostic Index (NCCN-IPI) risk score of ≥ 2
- Measurable disease, meaning at least 1 lymph node or other lymphomatous lesion with a long axis of ≥1.5 cm by CT imaging, and at least one FDG-avid lesion by FDG-PET scan.
- Left ventricular ejection fraction of at least 45% by either echocardiography or radionucleotide angiography.
- Ability to swallow oral tablets without difficulty.
- All people with preserved reproductive potential must agree to practice abstinence or employ contraceptive measures for the duration of treatment and for 10 months (if female) or 7 months (if male) following final...
- Meet the following clinical laboratory requirements:
- Creatinine clearance ≥30 ml/min by Cockcroft-Gault formula;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 3 × ULN;
- Platelet count ≥ 50,000/µL, with or without transfusion support;
- Absolute Neutrophil Count (ANC) ≥ 1000/µL, with or without chronic granulocyte growth factor support;
- Hemoglobin ≥8 g/dL, with or without transfusion support.
- Allergy or intolerance to roflumilast.
- Allergy or intolerance to loncastuximab
- Any active malignancy other than DLBCL
- Current participation in another treatment clinical study
- Prior allogeneic bone marrow transplant within 12 months of screening date.
- Prior autologous stem cell transplant within 6 months of screening date.
- Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing.
- Active central nervous system (CNS) involvement by lymphoma, including untreated symptomatic epidural disease.
- Active uncontrolled infection.
- Poorly controlled depressive symptoms and/ or currently under management for depression that is poorly controlled.
- Significant disease or medical conditions, as assessed by the Investigator and Sponsor, that would substantially increase the risk benefit ratio of participating in the study. This includes, but is not limited to, acute...
- Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which people are not on active anti-cancer therapies and have had no evidence of...
- History of major surgery within 3 weeks or minor surgery within 1 week of roflumilast administration. Major surgery includes, for example, any open or laparoscopic entry into a body cavity, or operative repair of...
- Other medical or psychiatric illnesses or organ dysfunction, which in the opinion of the investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent.
- Corrected QT interval (QTc) prolongation (defined as a QTc \>450 ms for males and \>470 ms for females -Fridericia's correction-) or other clinically significant ECG abnormalities as assessed by the investigator.
- Baseline serum troponin above the upper limit of normal.
- Baseline serum brain natriuretic peptide (BNP )above the age-adjusted upper limit of normal.
- Baseline amylase above the upper limit of normal.
- people known to be HIV-positive must not have multi-drug resistant HIV infection, cluster of differentiation 4 (CD4) counts \< 150/µl or other concurrent AIDS-defining conditions. Serologic screening for HIV is required...
- people positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C-virus ribonucleic acid (HCV RNA), unless both AST and ALT≤1.25 x ULN and there is no known history of chronic active hepatitis. Serologic screening...
- people with moderate or severe liver impairment, as defined by a Child-Pugh class of B or C.
- Women who are pregnant or breastfeeding.
- Current use of any of the following medications: boceprevir, carbamazepine, ciprofloxacin, cobicistat, conivaptan, enzalutamide, fluvoxamine, itraconazole, ketoconazole, mitotane, phenytoin, posaconazole, rifampin...
- Current use of non-nucleoside reverse transcriptase inhibitors (NNRTI) including efavirenz, rilpivirine, etravirine, delavirdine, nevirapine, and lersivirine.
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, 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 San Antonio, 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.