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

Genentech

Status and phase

Completed

Phase 1

Conditions

Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Treatments

Drug: rituximab

Drug: DCDT2980S

Study type

Interventional

Funder types

Industry

Identifiers

NCT01209130

DCT4862g

GO01295 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No 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