TAFASITAMAB for Malignant B-cell lymphoma|Diffuse large B-cell lymphoma|Follicular lymphoma grade 3B|Transformed indolent B-cell lymphoma

Inclusion criteria

• {"criterion_text":"- Histologically proven diagnosis of a) diffuse large cell B-cell lymphoma, and other aggressive B-cell lymphomas according to the WHO 2016 revision (specified in detail in the protocol) b) follicular lymphoma grade 3B and c) transformed indolent B-cell lymphoma (not more than 20 % of the patient population) according to the WHO classification (central pathology review)\n- Signed informed consent\n- Adequate contraception (if needed)\n- Relapsed disease or refractory disease, at least one but no more than two prior treatment lines\n- age ≥ 18 years\n- No curative option available (age ≥ 65yr and/or HCT-CI Score > 2) or s.p. HDT\n- At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration\n- Adequate bone marrow reserve: a) Platelets of at least 100 000/μl b) absolute neutrophil count of at least 1000/μl\n- Adequate hepatic and renal function: a) Alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN) b) Aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN) c) Total bilirubin <1.5 x upper limit of normal (ULN) unless related to lymphoma\n- Measured or calculated eGFR >50 ml/min (institutional standard)\n- Eastern Cooperative Oncology Group (ECOG) performance Status ≤2, unless tumor associated and expected to improve on treatment"}

Exclusion criteria

• {"criterion_text":"- CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)\n- Hepatitis C\n- active Hepatitis B, patients with HBs-Ag positivity and no measurable HBV-DNA are eligible\n- Medical or psychological condition that would not permit completion of the trial or signing of informed consent\n- Diagnosed or treated for a malignancy other than NHL except: a) adequately treated non-melanoma skin cancer b) curatively treated in-situ cancer of the cervix c) ductal carcinoma in situ (DCIS) of the breast d) other solid tumors curatively treated with no evidence of disease for >2 years e) prostate cancer with a life expectancy of more than 2 years\n- Concurrent treatment with another investigational agent or within the last 6 weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded\n- Known intolerance to any of the study drugs or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product\n- no adequate pretreatment (R-CHOP-like, or BR for initial indolent lymphoma)\n- systemic treatment within last 6 weeks, steroids for bridging are allowed\n- prior allogeneic transplantation prior anti CD19 CAR T-cell therapy or prior Tafasitamab therapy\n- pregnant or breast-feeding women\n- severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinemia)\n- Prolongation of QTc interval > 450 ms, demonstrated in electrocardiogramm (two separate or one in triplicate) or family history for Long QT-syndrome\n- active uncontrolled infections\n- HIV positivity"}

Primary endpoints

• {"endpoint_text":"- ORR of the regimen within the first 8 treatment cycles","definition_or_measurement_approach":"Analysis will be based on Lugano -Criteria"}

Secondary endpoints

• {"endpoint_text":"- ORR (Cheson 2007-criteria)\n- Progression free survival (Lugano)\n- Overall survival\n- CR-Rate (Lugano)\n- Best response (Lugano)\n- Quality of Life measured with EORTC QLQ C30 and NHL-HG29 (global QoL, physical functioning, fatigue)\n- ORR in separate GCB vs. non GCB-analysis is planned\n- Safety Endpoints: Safety and tolerability as measured by rate of AE, SAE compared between Arm A and B","definition_or_measurement_approach":"ORR (Cheson 2007 criteria); PFS and CR-Rate and Best response measured per Lugano criteria; QoL measured with EORTC QLQ-C30 and NHL-HG29 instruments; Safety by incidence/rate of AEs and SAEs compared between arms. Separate analysis planned for GCB vs non-GCB."}

Germany

Earliest CTIS Part Ii Submission Date

13-08-2024

Latest Decision Or Authorization Date

22-08-2024

Processing Time Days

9

Number Of Sites

11

Number Of Participants

64

Primary sponsor

Full Name

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"United States","full_name":"Incyte Corporation","duties_or_roles":"Source of monetary support","organisation_type":""}