A Study of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01290549
First received: February 3, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This is a Phase I, multicenter, open-label, dose-escalation study of DCDS4501A a dministered as a single agent by IV infusion to patients with relapsed or refrac tory hematologic malignancies. In Phase Ib, patients will receive DCDS4501A in c ombination with rituximab.


Condition Intervention Phase
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia
Drug: DCDS4501A
Drug: rituximab
Phase 1

Study Type: Interventional
Study Design: Allocation: 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 DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Nature of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Nature of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Severity of adverse events [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies (ATAs) against DCDS4501A [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: March 2011
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: DCDS4501A
Escalating intravenous dose
Experimental: Phase Ib Drug: DCDS4501A
Escalating intravenous dose
Drug: rituximab
375 mg/m2 iv, Day 1 of each 21-day cycle

  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 one of the following histologically-documented hematologic malignancy for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), Grade 3b FL, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
  • All patients (NHL and B-CLL) must have at least one bi-dimensionally measurable lesion
  • For all men or women of childbearing potential (unless surgically sterile): use of adequate methods of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly

Exclusion Criteria:

  • Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before Cycle 1, Day 1
  • Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1. Adverse events from any previous treatments must be resolved or stabilized prior to Cycle 1, Day 1, except for neuropathy
  • Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
  • 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: NCT01290549

Locations
United States, California
Stanford, California, United States, 94305-5820
United States, Florida
Sarasota, Florida, United States, 34232
United States, New York
Buffalo, New York, United States, 14263
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle, Washington, United States, 98109
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1H6
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
France
Dijon, France, 21000
Lille, France
Montpellier, France, 34295
Pierre Benite, France, 69495
Rouen, France, 76038
Netherlands
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Yu-Waye Chu, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01290549     History of Changes
Other Study ID Numbers: DCS4968g, GO01294
Study First Received: February 3, 2011
Last Updated: October 6, 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 October 19, 2014