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A Study of GDC-0199 (ABT-199) in Combination With Bendamustine And MabThera/Rituxan in Patients With Chronic Lymphocytic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Genentech, Inc.
Sponsor:
Collaborator:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01671904
First received: August 10, 2012
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This multi-center, open-label, dose-finding study will evaluate the safety and p harmacokinetics of GDC-0199 (ABT-199) administered in combination with bendamust ine and MabThera/Rituxan (rituximab) to patients with relapsed/refractory or pre viously untreated chronic lymphocytic leukemia.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: GDC-0199 (ABT-199)
Drug: bendamustine
Drug: rituximab [MabThera/Rituxan]
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Bendamustine/Rituximab (BR) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Area under the concentration time curve [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GDC-0199 (ABT-199) Arm Drug: GDC-0199 (ABT-199)
Multiple doses of GDC-0199 (ABT-199)
Drug: bendamustine
Multiple doses of bendamustine
Drug: rituximab [MabThera/Rituxan]
Multiple doses of MabThera/Rituxan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia
  • Eastern Cooperative Oncology Group (ECOG) performance score of >/=1
  • Adequate bone marrow function
  • Adequate renal and hepatic function

Exclusion Criteria:

  • Patient received an allogeneic stem cell transplant
  • Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
  • Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
  • Investigational or anti-cancer therapy within 14 days of study start (30 days for biologic agents for anti-neoplastic intent)
  • History of significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
  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: NCT01671904

Contacts
Contact: Reference Study ID Number: GO28440 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
La Jolla, California, United States, 92093
United States, Illinois
Recruiting
Harvey, Illinois, United States, 60426
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
United States, Washington
Terminated
Spokane, Washington, United States, 99218
Terminated
Yakima, Washington, United States, 98902
Recruiting
Yakima, Washington, United States, 98902
France
Recruiting
Lille, France, 59037
Recruiting
Montpellier, France, 34295
Recruiting
Pierre Benite, France, 69495
Recruiting
Rouen, France, 76038
Germany
Recruiting
Freiburg, Germany, 79106
Recruiting
Kiel, Germany, 24116
Recruiting
Koeln, Germany, 50937
Recruiting
München, Germany, 80804
Recruiting
Ulm, Germany, 89081
Sponsors and Collaborators
Genentech, Inc.
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01671904     History of Changes
Other Study ID Numbers: GO28440, 2012-002351-42
Study First Received: August 10, 2012
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014