An explorative and feasibility study of Venetoclax combined with Tamoxifen in patients with relapsed/refractory Diffuse Large B-cell Lymphoma

Tamoxifen and Venetoclax in R/R DLBCL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20687

Enrollment

Registered

2020-11-25

Start date

2021-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

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)

Eligibility

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 (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

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 outcomes

Primary

Measure	Time frame
Descriptive analyses of safety and toxicity (using SAE grade 3 and 4 listing) of tamoxifen and venetoclax	—

Secondary

Measure	Time frame
• 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	—

Contacts

Public ContactMargriet Dijkstra

UMCG

m.j.dijkstra-tiekstra@umcg.nl+31 50 3610468

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)