Primary treatment of follicular lymphoma with rituximab-lenalidomide-tafasitamab for high-risk disease and rituximab-lenalidomide with a 1:1 randomization to tafasitamab for low-risk disease: a phase II study – NLG-FL7

Trial details

Who runs it

Karolinska University Hospital

Trial code

EU 2023-508196-36-00

Record updated

2026. június 16.

Original description

To assess the efficacy of the addition of tafasitamab to rituximab-lenalidomide in primary treatment of follicular lymphoma.Read full original descriptionShow less

To assess the efficacy of the addition of tafasitamab to rituximab-lenalidomide in primary treatment of follicular lymphoma.

Inclusion: Written informed consent according to ICH-GCP guidelines; Age ≥ 18 and ≤ 85 years; Histologically confirmed follicular lymphoma (not grade 3B) stage II-IV not suitable for radiotherapy (preferably a surgical biopsy, core but not fine needle acceptable); At least one two-dimensionally measurable lesion with a longest diameter > 15 mm; WHO performance status 0-2; At least one treatment indication of the following: 1. Symptomatic disease 2. Vital organ or vascular compression 3. Ascites or pleural effusion 4. Bulky disease (≥ 6 cm) 5. Steady, clinically significant progression over at least 3 months of any tumour lesion 6. B-symptoms (weight loss > 10% in 6 months, drenching night sweats or fever > 38°C not due to infection) 7. Anemia (hemoglobin < 100 g/L) or thrombocytopenia (platelets < 100 x 109/L) due to lymphoma; Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, only after A. leaving a negative result on a highly sensitive pregnancy test, B. are using a highly effective method of contraception during treatment, and C. throughout the study and 4 weeks after the last dose of lenalidomide, 3 months after the last dose of tafasitamab and 12 months after the last dose of rituximab, whichever is latest. (An additional pregnancy test is to be provided at end of exposure). Highly effective methods of contraception include one or more of the following (see also Appendix 6): a. male partner who is sterile (vasectomised) prior to the female study subject’s entry into the study and is the sole sexual partner for the female subject; b. hormonal (oral, intravaginal, transdermal, implantable or injectable) c. an intrauterine hormone-releasing system (IUS) d. an intrauterine device (IUD) with a documented failure rate of < 1%; Sexually active male participants must agree to use barrier prevention (condom) to ensure that embryos/fetuses are not exposed to study drugs via sperm, during treatment and for a week after completion of treatment. Female partners to male participants must if not postmenopausal or permanently sterilized (e.g. hysterectomy or tubal ligation) use a highly effective method of contraception to avoid accidental pregnancy during treatment and for a week after the last dose of lenalidomide.

Exclusion: Subjects with a previous HCV infection will be eligible if they are negative for HCV-RNA; Transformation to aggressive lymphoma (including grade 3B follicular lymphoma) at any time prior to starting treatment within the trial; CNS involvement of lymphoma at inclusion or previously; Previous systemic anti-lymphoma therapy, including chemotherapy or antibodies; however, steroids to alleviate lymphoma symptoms and preclude tumor lysis prior to and during the first course of trial therapy are allowed; Anti-lymphoma radiotherapy <3 months prior to start of trial therapy (local radiotherapy before that timepoint is allowed); Known history of drug induced liver injury, alcoholic liver disease, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension; Hepatitis B (HBV): a history of past or present hepatitis B infection (according to serology or DNA) is not allowed; Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, low grade prostate cancer without therapy, and carcinoma in situ of the cervix, or other noninvasive or indolent malignancy; Psychiatric disorder or dementia which make the patient unable to give an informed consent and/or adhere to the schedule; HIV positivity; Patients with an active infection which needs clinical intervention; Severe cardiac disease: cardiac function (NYHA III or IV); Estimated glomerular filtration rate (eGFR) <10 mL/min, using the Cockcroft-Gault equation, even if caused by lymphoma; Impaired bone marrow function (neutrophils < 1.0 x 109/L or platelets < 50 x 109/L) unless due to lymphoma involvement; Impaired liver function not caused by lymphoma, defined as serum total bilirubin > 2 x ULN (> 3 x ULN if Gilbert’s syndrome) or serum ALT and AST ˃ 3 x ULN; Estimated glomerular filtration rate (eGFR) <30 mL/min, using the Cockcroft-Gault equation, if not caused by lymphoma; CD20-negative or CD19-negative lymphoma; Other major organ dysfunction not caused by lymphoma; Patients with other severe medical problems causing an expected survival <1 year for non-lymphoma reasons; Pregnancy or breast-feeding; Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment; Unwilling or unable to take prophylaxis against a thromboembolic event.

EU CTIS 2023-508196-36-00