TAFASITAMAB for Follicular lymphoma

Inclusion criteria

• {"criterion_text":"- Written informed consent according to ICH-GCP guidelines\n- Age ≥ 18 and ≤ 85 years\n- Histologically confirmed follicular lymphoma (not grade 3B) stage II-IV not suitable for radiotherapy (preferably a surgical biopsy, core but not fine needle acceptable)\n- At least one two-dimensionally measurable lesion with a longest diameter > 15 mm\n- WHO performance status 0-2\n- At least one treatment indication of the following: 1. Symptomatic disease \t2. Vital organ or vascular compression 3. Ascites or pleural effusion 4. Bulky disease (≥ 6 cm) \t5. Steady, clinically significant progression over at least 3 months of any tumour lesion\t6. B-symptoms (weight loss > 10% in 6 months, drenching night sweats or fever > 38°C not due to infection) \t7. Anemia (hemoglobin < 100 g/L) or thrombocytopenia (platelets < 100 x 109/L) due to lymphoma\n- 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.\tmale 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.\thormonal (oral, intravaginal, transdermal, implantable or injectable) c.\tan intrauterine hormone-releasing system (IUS) d. an intrauterine device (IUD) with a documented failure rate of < 1%.\n- 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 criteria

• {"criterion_text":"- CD20-negative or CD19-negative lymphoma\n- Estimated glomerular filtration rate (eGFR) <10 mL/min, using the Cockcroft-Gault equation, even if caused by lymphoma\n- Other major organ dysfunction not caused by lymphoma\n- 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\n- Hepatitis B (HBV): a history of past or present hepatitis B infection (according to serology or DNA) is not allowed.\n- Subjects with a previous HCV infection will be eligible if they are negative for HCV-RNA.\n- Patients with other severe medical problems causing an expected survival <1 year for non-lymphoma reasons\n- 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\n- Psychiatric disorder or dementia which make the patient unable to give an informed consent and/or adhere to the schedule\n- Pregnancy or breast-feeding\n- HIV positivity\n- Transformation to aggressive lymphoma (including grade 3B follicular lymphoma) at any time prior to starting treatment within the trial\n- 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\n- Unwilling or unable to take prophylaxis against a thromboembolic event\n- Patients with an active infection which needs clinical intervention\n- CNS involvement of lymphoma at inclusion or previously\n- 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\n- Anti-lymphoma radiotherapy <3 months prior to start of trial therapy (local radiotherapy before that timepoint is allowed)\n- Impaired bone marrow function (neutrophils < 1.0 x 109/L or platelets < 50 x 109/L) unless due to lymphoma involvement\n- Severe cardiac disease: cardiac function (NYHA III or IV)\n- 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\n- Estimated glomerular filtration rate (eGFR) <30 mL/min, using the Cockcroft-Gault equation, if not caused by lymphoma"}

Primary endpoints

• {"endpoint_text":"- EFS24, defined as the interval between treatment start and progression or new lymphoma treatment or death, whichever occurs first, within 2 years of study entry.","definition_or_measurement_approach":"EFS24 is defined as the interval between treatment start and progression or new lymphoma treatment or death, whichever occurs first, within 2 years of study entry."}

Secondary endpoints

• {"endpoint_text":"- EFS, defined as the interval between treatment start and progression or new lymphoma treatment or death, whichever occurs first.","definition_or_measurement_approach":"EFS is defined as the interval between treatment start and progression or new lymphoma treatment or death, whichever occurs first."}
• {"endpoint_text":"- PFS, defined as the interval between treatment start and progression or death, whichever occurs first.","definition_or_measurement_approach":"PFS is defined as the interval between treatment start and progression or death, whichever occurs first."}
• {"endpoint_text":"- POD24, defined as the interval between treatment start and progression or death, whichever occurs first, within 2 years of study entry.","definition_or_measurement_approach":"POD24 is defined as the interval between treatment start and progression or death, whichever occurs first, within 2 years of study entry."}
• {"endpoint_text":"- OS, defined as the interval between treatment start and death.","definition_or_measurement_approach":"OS is defined as the interval between treatment start and death."}
• {"endpoint_text":"- ORR, defined as the sum of the rates of CR or PR at best response.","definition_or_measurement_approach":"ORR is defined as the sum of the rates of CR or PR at best response."}
• {"endpoint_text":"- CRR, defined as the sum of the rates of CR at best response.","definition_or_measurement_approach":"CRR is defined as the sum of the rates of CR at best response."}
• {"endpoint_text":"- LSS, defined as the interval between treatment start and death of lymphoma (other causes are censored at the date of death).","definition_or_measurement_approach":"LSS is defined as the interval between treatment start and death of lymphoma (other causes are censored at the date of death)."}
• {"endpoint_text":"- Time to next treatment, defined as the interval between treatment start and that of documented new anti-lymphoma therapy.","definition_or_measurement_approach":"Time to next treatment is defined as the interval between treatment start and that of documented new anti-lymphoma therapy."}
• {"endpoint_text":"- Duration of response, defined as the interval between when criteria for response (CR or PR) are met to the first documentation of progression.","definition_or_measurement_approach":"Duration of response is defined as the interval between when criteria for response (CR or PR) are met to the first documentation of progression."}
• {"endpoint_text":"- Incidence of transformation. Cases of transformation are documented with respect to transformation type and date.","definition_or_measurement_approach":"Incidence of transformation documented with respect to transformation type and date."}
• {"endpoint_text":"- Safety based on the incidence and severity of AEs. Frequency and duration of all grade 3-5 treatment-related adverse events (AEs) according to CTCAE 5.0.","definition_or_measurement_approach":"Safety measured by incidence and severity of AEs; frequency and duration of all grade 3-5 treatment-related AEs according to CTCAE 5.0."}
• {"endpoint_text":"- HR-QoL as measured by EORTC QLQ-C30","definition_or_measurement_approach":"Health-related quality of life measured using the EORTC QLQ-C30 instrument."}

Iceland

Earliest CTIS Part Ii Submission Date

30-01-2025

Latest Decision Or Authorization Date

28-04-2025

Processing Time Days

88

Number Of Sites

1

Number Of Participants

25

Denmark

Earliest CTIS Part Ii Submission Date

11-02-2025

Latest Decision Or Authorization Date

28-04-2025

Processing Time Days

76

Number Of Sites

5

Number Of Participants

60

Sweden

Earliest CTIS Part Ii Submission Date

06-02-2025

Latest Decision Or Authorization Date

28-04-2025

Processing Time Days

81

Number Of Sites

7

Number Of Participants

80

Finland

Earliest CTIS Part Ii Submission Date

04-02-2025

Latest Decision Or Authorization Date

28-04-2025

Processing Time Days

83

Number Of Sites

5

Number Of Participants

50

Norway

Earliest CTIS Part Ii Submission Date

31-01-2025

Latest Decision Or Authorization Date

28-04-2025

Processing Time Days

87

Number Of Sites

4

Number Of Participants

55

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"QP release","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"","organisation_type":"Educational Institution"}