NCT01209130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4.4 years

First QC Date

September 23, 2010

Last Update Submit

November 1, 2016

Conditions

Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Incidence and nature of dose-limiting toxicities (DLTs)

    Throughout study or until early discontinuation

Secondary Outcomes (1)

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

    Throughout study or until early discontinuation

Study Arms (2)

A

EXPERIMENTAL
Drug: DCDT2980S

B

EXPERIMENTAL
Drug: DCDT2980SDrug: rituximab

Interventions

DCDT2980SDRUG

Intravenous repeating dose

AB
rituximabDRUG

Intravenous repeating dose

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Stanford, California, 94305-5821, United States

Location

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20057, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109, United States

Location

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

pinatuzumab vedotinRituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2010

First Posted

September 27, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(9)