relapsed/refractory Diffuse Large B-cell Lymphoma
Conditions
Interventions
Trade Name: Venclyxto
Pharmaceutical Form: Film-coated tablet
Trade Name: Tamoxifen
Pharmaceutical Form: Film-coated tablet
Sponsors
Medical University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients of 18 years and older and under the age of 70 with a diagnosis of Diffuse Large B-cell lymphoma (according WHO 2016) and refractory after 2 lines of therapy for patients ineligible for CAR T-cell therapy and after CAR T-cell therapy (hence after 3rd line of therapy). Patients with relapsed/refractory DLBCL older than 70 years after at least 1 line of conventional chemotherapy or after CAR T-cell therapy. • Written informed consent. • No known allergy to Ven or Tam. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
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 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the safety of Tamoxifen added to Venetoclax. Venetoclax will be dosed at 800 mg once daily. After 2 days of venetoclax, tamoxifen will be orally administrated in a ramp-up phase (2 days 10mg, 2 days 20mg, to a final dose of 40 once daily, see study scheme) ;Secondary Objective: ? To assess the efficacy of Tam added to Ven. An FDG PET /CT scan will be performed at day +28 and day +90 of the treatment ? To assess the duration of response (DOR) ? To assess the progression free survival (PFS) ? To assess the overall survival (OS) ;Primary end point(s): ? Descriptive analyses of safety and toxicity (using SAE grade 3 and 4 listing) of tamoxifen and venetoclax.;Timepoint(s) of evaluation of this end point: at entry, prior to first administration, and 24h, 72h, 7 days, 28 days and 90 days after first administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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 ;Timepoint(s) of evaluation of this end point: at entry, prior to first administration, and 24h, 72h, 7 days, 28 days and 90 days after first administration | — |
Countries
Netherlands
Contacts
Public ContactTrial Data Center Hematology
University Medical Center Groningen
Outcome results
None listed