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

Conditions

• Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DCDT2980S — DRUG
  Intravenous repeating dose
• rituximab — DRUG
  Intravenous repeating dose

Study Details

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 Dates

Start date

Oct 31, 2010

Status verified

Nov 2016

Primary completion

Mar 31, 2015

Completion

Mar 31, 2015

Study Design

Enrollment

91 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: A
• Experimental: B

Primary Outcome Measure

Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Throughout study or until early discontinuation ]

Locations (9)