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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01209130
First Posted: September 27, 2010
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition Intervention Phase
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia Drug: DCDT2980S Drug: rituximab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

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

Secondary Outcome Measures:
  • Objective response, defined as a partial response (PR) or complete response (CR) [ Time Frame: Throughout study or until early discontinuation ]

Enrollment: 91
Study Start Date: October 2010
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: DCDT2980S
Intravenous repeating dose
Experimental: B Drug: DCDT2980S
Intravenous repeating dose
Drug: rituximab
Intravenous repeating dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209130


Locations
United States, California
Stanford, California, United States, 94305-5821
United States, Colorado
Denver, Colorado, United States, 80218
United States, District of Columbia
Washington, District of Columbia, United States, 20057
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, Oregon
Portland, Oregon, United States, 97239
United States, Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01209130     History of Changes
Other Study ID Numbers: DCT4862g
GO01295 ( Other Identifier: Hoffmann-La Roche )
First Submitted: September 23, 2010
First Posted: September 27, 2010
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents