drugset / Trial / NCT03886649

Copanlisib in Combination With Venetoclax in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.

NCT03886649

Phase 1 Terminated 7 enrolled Swiss Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

A significant number of patients with non-Hodgkin lymphoma (NHL) are not cured with available treatments and will eventually relapse. Those patients might not be able to tolerate more bone marrow toxicity, limiting their treatment options. Preclinical in vitro studies have demonstrated a synergism of venetoclax and copanlisib in different lymphomas. This may represent a safe and effective therapy for patients who relapsed or did not respond to standard therapy. The primary objective of this phase I trial is to establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of copanlisib in combination with venetoclax in patients with relapsed or refractory B-cell NHL.

Timeline

Start
2019-11-04
Primary completion
2021-05-10
Completion
2022-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Copanlisib Small molecule 60 mg Intravenous
Subject Venetoclax Small molecule 600 mg

Indications