NCT02453087

A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

An Open-label, Multicenter, Phase 1/1b Dose Escalation Study Evaluating the Pharmacokinetics, Safety, Tolerability, and Preliminary Efficacy of DCDS0780A, Alone or in Combination With Rituximab, or Obinutuzumab, in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multicenter, Phase 1/1b study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of DCDS0780A in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma. In the combination portion of the study, the safety and tolerability of DCDS0780A in combination with rituximab or obinutuzumab will be assessed.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	DCDS0780A	Participants will receive escalating doses of DCDS0780A as intravenous infusion.
DRUG	Rituximab	Participants will receive rituximab at a dose of 375 mg/m\^2 of body surface area as intravenous infusion.
DRUG	Obinutuzumab	Participants will receive obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion.

Timeline

• Start date: 2015-08-04
• Primary completion: 2019-07-12
• Completion: 2019-07-12
• First posted: 2015-05-25
• Last updated: 2019-08-29

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study