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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

Primary Purpose

Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DCDT2980S

rituximab

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Incidence and nature of dose-limiting toxicities (DLTs)

Secondary Outcome Measures

Objective response, defined as a partial response (PR) or complete response (CR)

Full Information

NCT ID

NCT01209130

First Posted

September 23, 2010

Last Updated

November 1, 2016

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01209130

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

DCDT2980S

Intervention Description

Intravenous repeating dose

Intervention Type

Drug

Intervention Name(s)

rituximab

Intervention Description

Intravenous repeating dose

Primary Outcome Measure Information:

Title

Incidence and nature of dose-limiting toxicities (DLTs)

Time Frame

Throughout study or until early discontinuation

Secondary Outcome Measure Information:

Title

Objective response, defined as a partial response (PR) or complete response (CR)

Time Frame

Throughout study or until early discontinuation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

Facility Information:

City

Stanford

State/Province

California

ZIP/Postal Code

94305-5821

Country

United States

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20057

Country

United States

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

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