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HOVON 161: A phase II non-inferiority study comparing point-of-care produced CAR T-cell to commercial CAR T-cells in patients with relapsed/refractory Non-Hodgkin Lymphoma
EU CTIS ID: 2024-511979-15-00
What this study is testing
To compare progression free survival (PFS) of patients randomized to investigational point-of-care (PoC) ARI-0001 CAR T-cells versus PFS of patients randomized to commercial standard-of-care (SoC) (axicabtagene ciloleucel (Axi-cel, Yescarta)) CAR T-cells in patients with R/R DLBCL.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B, T-cell/histocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, transformed lymphoma (transformed follicular) and refractory after 1st line systemic therapy or have a relapse after 12 months of finishing first line therapy or have R/R after at least 2 lines of systemic therapy
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0-2.
- Secondary central nervous system (CNS) involvement is allowed however, then he/she must have no signs or symptoms of CNS involvement that would hamper adequate ICANS assessment.
- Estimated life expectancy of >3 months other than primary disease.
- Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen.
You likely can't join if
- Absolute neutrophil count (ANC) <1.0x109/L.
- Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease.
- Active systemic autoimmune disease for which immunnosupressive therapy is required.
- Presence of CNS disease that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity, baseline dementia that would interfere with therapy or monitoring, determined using mini-mental status exam at baseline.
- Active systemic fungal, viral or bacterial infection.
- Clinical heart failure with New York Heart Association class ≥2 or Left Ventricular Ejection Fraction (LVEF) <40%.
See the full eligibility criteria
Who can join
- Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B, T-cell/histocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, transformed lymphoma (transformed follicular) and refractory after 1st line systemic therapy or have a relapse after 12 months of finishing first line therapy or have R/R after at least 2 lines of systemic therapy
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0-2.
- Secondary central nervous system (CNS) involvement is allowed however, then he/she must have no signs or symptoms of CNS involvement that would hamper adequate ICANS assessment.
- Estimated life expectancy of >3 months other than primary disease.
- Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen.
- Signed and dated informed consent before conduct of any trial-specific procedure.
- Patient is capable of giving informed consent.
- Approval by the Dutch CAR T-cell TumorBoard for lymphoma
What rules you out
- Absolute neutrophil count (ANC) <1.0x109/L.
- Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease.
- Active systemic autoimmune disease for which immunnosupressive therapy is required.
- Presence of CNS disease that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity, baseline dementia that would interfere with therapy or monitoring, determined using mini-mental status exam at baseline.
- Active systemic fungal, viral or bacterial infection.
- Clinical heart failure with New York Heart Association class ≥2 or Left Ventricular Ejection Fraction (LVEF) <40%.
- Resting oxygen saturation <92% on room air.
- Liver dysfunction as indicated by total bilirubin, AST and/or ALT >5 x institutional ULN, unless directly attributable to the lymphoma or Gilbert disease.
- GFR <40 mL/min calculated according to the modified formula of Cockcroft and Gault or by direct urine collection.
- Pregnant or breast-feeding woman.
- Active other malignancy requiring treatment.
- Platelet count <50x109/L.
- Medical condition requiring prolonged use of systemic immunosuppressives with exception of prednisolone <10 mg/day.
- History of severe immediate hypersensitivity reaction against any drug or its Ingredients/ impurities that is scheduled to be given during trial participation e.g. as part of the mandatory lymphodepletion protocol, premedication for infusion, or rescue medication/salvage therapies for treatment related toxicities.
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Absolute lymphocyte count <0.1x109/L.
- Primary CNS lymphoma.
- Known history of infection with hepatitis C or B virus unless treated and confirmed to be polymerase chain reaction (PCR) negative.
- Active HIV infection with detectable viral load or CD4 T-cell count below 0.20x109/L.
- Known history or presence of seizure activities or on active anti- seizure medications within the previous 12 months.
- Known history of CVA within prior 12 months.
- Unstable neurological deficits.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.