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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
Not Recruiting
Trial ID: NCT01209130
Purpose
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.
Official Title
An Open-Label, Multicenter, Phase I Trial 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
Eligibility
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
Intervention(s):
drug: rituximab
drug: DCDT2980S
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061