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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01209130
First received: September 23, 2010
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S a dministered by intravenous (IV) infusion to patients with relapsed or refractory hematologic malignancies. In addition, at selected sites, DCDT2980S will be stu died 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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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:

Primary Outcome Measures:
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response, defined as a partial response (PR) or complete response (CR) [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01209130     History of Changes
Other Study ID Numbers: DCT4862g, GO01295
Study First Received: September 23, 2010
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014