drugset / Trial / NCT04074330

A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma

NCT04074330

Phase 1/2 Terminated 38 enrolled Takeda
Non-randomizedSequentialOpen-labelTreatment

Summary

This study is about a medicine called TAK-981 given with rituximab, used to treat adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma. This study has 2 parts. The main aims of the study are: * To check for side effects from treatment with TAK-981 given with rituximab. * To check how much TAK-981 participants can tolerate. * To check if participants with diffuse large B-cell lymphoma or follicular lymphoma respond well to treatment. Participants will receive TAK-981 and rituximab in 21-day cycles. They will continue treatment for about 12 months unless their condition gets worse (disease progression), they cannot tolerate the treatment, or they leave the study for certain reasons.

Timeline

Start
2019-10-15
Primary completion
2023-04-26
Completion
2023-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject TAK-981 Small molecule 10 mg Intravenous
Subject TAK-981 Small molecule 40 mg Intravenous
Subject TAK-981 Small molecule 60 mg Intravenous
Subject TAK-981 Small molecule 90 mg Intravenous
Subject TAK-981 Small molecule 120 mg Intravenous

Indications