Status:
COMPLETED
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
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01209130
Start Date
October 1 2010
End Date
March 1 2015
Last Update
November 2 2016
Active Locations (9)
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1
Stanford, California, United States, 94305-5821
2
Denver, Colorado, United States, 80218
3
Washington D.C., District of Columbia, United States, 20057
4
Boston, Massachusetts, United States, 02114