A Study of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma

Phase 1

Completed

• Conditions: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
• Interventions: Drug: DCDT2980S; Drug: rituximab

• Registration Number: NCT01209130
• Lead Sponsor: Genentech, Inc.

Brief Summary

This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S administered by intravenous (IV) infusion to patients with relapsed or refractory hematologic malignancies. In addition, at selected sites, DCDT2980S will be studied in combination with rituximab.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-27
• Study Start: 2010-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Life expectancy of at least 12 weeks
• History of histologically-documented hematologic malignancy for which no effective standard therapy exists: indolent NHL (including Grades 1-3a FL; MZL [including splenic, nodal, and extra-nodal]; and SLL), Grade 3b FL, DLBCL, MCL, or CLL
• Must have at least one bi-dimensionally measurable lesion

Exclusion Criteria

• Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks prior to study treatment
• Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to of study treatment
• Completion of autologous stem cell transplant within 100 days prior to study treatment
• Prior allogeneic stem cell transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	DCDT2980S	-
B	DCDT2980S	-
B	rituximab	-

Primary Outcome Measures

Name	Time	Method
Incidence and nature of dose-limiting toxicities (DLTs)	Throughout study or until early discontinuation

Secondary Outcome Measures

Name	Time	Method
Objective response, defined as a partial response (PR) or complete response (CR)	Throughout study or until early discontinuation