An explorative and feasibility study of Venetoclax combined with Tamoxifen in patients with relapsed/refractory Diffuse Large B-cell Lymphoma
- Conditions
- 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.
- Registration Number
- NL-OMON20687
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
• 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.
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Descriptive analyses of safety and toxicity (using SAE grade 3 and 4 listing) of tamoxifen and venetoclax
- Secondary Outcome Measures
Name Time Method • 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. <br>• To assess the duration of response (DOR)<br>• To assess the progression free survival (PFS) after 3 months (after the first dose of TAM)<br>• To assess the overall survival (OS) after 3 months<br>