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

Completed · Phase 1

Conditions studied: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT01209130

Run by

Genentech, Inc.

People needed

91

Starts

2010-10-01

Expected to finish

2015-03-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Stanford, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Portland, Oregon, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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