No registrations found.
ID
Source
Brief title
Health condition
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.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Descriptive analyses of safety and toxicity (using SAE grade 3 and 4 listing) of tamoxifen and venetoclax
Secondary outcome
• To assess the effectivity of the combination Tam and Ven as measured by the day + 28 and +90 response as measured by FDG PET CT scan.
• To assess the duration of response (DOR)
• To assess the progression free survival (PFS) after 3 months (after the first dose of TAM)
• To assess the overall survival (OS) after 3 months
Background summary
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.
Study objective
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.
Study design
at entry, prior to start Venetoclax, 24h, 72h, 7 days, 28 days and 90 days after start Venetoclax
Intervention
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)
Inclusion criteria
• 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.
Exclusion criteria
• 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9075 |
| Other | METc UMCG : METc to be submitted |