Venetoclax, lenalidomide and rituximab in patients with relapsed/refractory mantle cell lymphoma. - VALERIA

ordic Lymphoma Group0 sites83 target enrollmentJanuary 11, 2018

Overview

No summary available.

Registry

who.int

Start Date

January 11, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ordic Lymphoma Group

•1\.Age \>18 years
•2\.Histologically confirmed (according to the WHO 2016 classification) mantle cell lymphoma stage I\-IV
•a.Who have received at least 1 prior rituximab\-containing chemotherapy regimen, with documented relapse or disease progression following
•the last anti\-MCL treatment
•b.Are not considered to be candidates for chemotherapy due to frailty or comorbidity
•4\.At least 1 measurable site of disease (\>1\.5 cm long axis)
•5\.WHO performance status 0 – 3
•6\.Written informed consent.
•7\.Female subjects of childbearing potential must (see page 52 for definition of not fertile):
•a.Understand that the study medication is expected to be teratogenic

•a.Chemotherapy or radiotherapy within 3 weeks
•b.Therapeutic antibodies or BTK inhibitors within 4 weeks
•c.Radioimmunotherapy within 10 weeks
•d.Major surgery within 4 weeks of inclusion in this trial.
•2\.Previous treatment with venetoclax
•3\.Impaired liver function: AST and ALT \>3\.0 × the upper normal limit (ULN) of institution's normal range; Bilirubin \> 1\.5 × ULN. Subjects with
•Gilbert's Syndrome may have a bilirubin \> 1\.5 × ULN, per discussion between the investigator and medical monitor. Elevated Bilirubin due
•to haemolytic anemia or caused by lymphoma, is not an exclusion criterion.
•4\.Absolute neutrophil count (ANC) \<1\.0x 109, unless caused by bone marrow infiltration by lymphoma.
•5\.Platelet count \<60 x 109, unless caused by bone marrow infiltration by lymphoma.