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



Status:Completed
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:October 2010
End Date:March 2015

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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

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.


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
We found this trial at
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