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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01209130

Enrollment

Registered

2010-09-27

Start date

2010-10-31

Completion date

2015-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

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.

Interventions

DRUGDCDT2980S

Intravenous repeating dose

DRUGrituximab

Intravenous repeating dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026