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
- Conditions
- Non-Hodgkin Lymphoma10025320
- Registration Number
- NL-OMON54144
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
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, EBV+ DLBCL, transformed lymphoma (transformed follicular) and R/R
after at least 2 lines of systemic therapy
• Age >= 18 years
• ECOG/WHO performance status >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
• Absolute neutrophil count (ANC) <1.0x109/L
• Platelet count <50x109/L
• 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 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
• 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 NYHA class >=2 or 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
• Medical condition requiring prolonged use of systemic immunosuppressives with
exception of prednisolon<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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method