TAM and ven can be used with acceptable safety and there will be a measurable overall respons. Study is exploratory, so no numbers are given yet.
ID
Bron
Verkorte titel
Aandoening
Patients with relapsed/refractory DLBCL younger than 70 years after at least 2 lines of conventional chemotherapy. Patients with relapsed/refractory DLBCL older than 70 years after at least 1 line of conventional chemotherapy.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Descriptive analyses of safety and toxicity (using SAE grade 3 and 4 listing) of tamoxifen and venetoclax
Achtergrond van het onderzoek
Patients with relapsed/refractory DLBCL in this study are treated with oral Venetoclax (Ven; 800 mg once daily) and oral Tamoxifen (Tam; starting with a ramp-up phase; 2 days 10mg, 2 days 20mg, and 40mg once daily). These doses are the approved doses for treatment of breast cancer (Tam) and the advised dose for the treatment of B-cell Non-Hodgkin Lymphoma (NHL). The main objectives are to asses safety and eficacy of Tam and Ven.
Doel van het onderzoek
TAM and ven can be used with acceptable safety and there will be a measurable overall respons. Study is exploratory, so no numbers are given yet.
Onderzoeksopzet
at entry, prior to start Venetoclax, 24h, 72h, 7 days, 28 days and 90 days after start Venetoclax
Onderzoeksproduct en/of interventie
Patients in this study are treated with oral Ven (800 mg once daily) and oral Tam (starting with a ramp-up phase; 2 days 10mg, 2 days 20mg, and 40mg once daily). These doses are the approved doses for treatment of breast cancer (Tam) and the advised dose for the treatment of B-cell Non-Hodgkin Lymphoma (NHL)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Patients of 18 years and older and under the age of 70 with a diagnosis of Diffuse Large B-cell lymphoma (DLBCL) and High-grade B-cell lymphoma (HGBCL) (according WHO 2016) and refractory after 2 lines of therapy. Patients with relapsed/refractory DLBCL/HGBCL older than 70 years after at least 1 line of conventional chemotherapy.
• Written informed consent.
• No known allergy to Ven or Tam.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Eastern Cooperative Oncology Group (ECOG) performance status >2
• Absolute neutrophil count (ANC) <1,000/µL
• Platelet count <50,000/µL
• Absolute lymphocyte count <100/µL
• Primary and secondary CNS lymphoma
• Active systemic fungal, viral or bacterial infection
• CrCl <30 mL/min calculated according to the modified formula of Cockcroft and Gault or by direct urine collection
• Pregnant or breast-feeding woman
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9075 |
| Ander register | METc UMCG : METc to be submitted |