- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01209130
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
November 1, 2016 updated by: Genentech, Inc.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305-5821
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Colorado
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Denver, Colorado, United States, 80218
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District of Columbia
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Washington, District of Columbia, United States, 20057
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Massachusetts
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Boston, Massachusetts, United States, 02215
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Boston, Massachusetts, United States, 02114
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Michigan
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Ann Arbor, Michigan, United States, 48109
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New Jersey
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Hackensack, New Jersey, United States, 07601
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Oregon
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Portland, Oregon, United States, 97239
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Wisconsin
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Madison, Wisconsin, United States, 53705
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
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Intravenous repeating dose
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Experimental: B
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Intravenous repeating dose
Intravenous repeating dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence and nature of dose-limiting toxicities (DLTs)
Time Frame: Throughout study or until early discontinuation
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Throughout study or until early discontinuation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response, defined as a partial response (PR) or complete response (CR)
Time Frame: Throughout study or until early discontinuation
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Throughout study or until early discontinuation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
September 23, 2010
First Submitted That Met QC Criteria
September 23, 2010
First Posted (Estimate)
September 27, 2010
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Lymphoma
- Lymphoma, B-Cell
- Leukemia
- Lymphoma, Non-Hodgkin
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- DCT4862g
- GO01295 (Other Identifier: Hoffmann-La Roche)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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