Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 10, 2012
November 4, 2014
January 2014
March 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01671904 on ClinicalTrials.gov Archive Site
Pharmacokinetics: Area under the concentration time curve [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
Pharmacokinetics: Area under the concentration time curve [ Time Frame: Pre-dose and up to 24 h post-dose of each dosing day ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of GDC-0199 (ABT-199) in Combination With Bendamustine And MabThera/Rituxan in Patients With Chronic Lymphocytic Leukemia
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphocytic Leukemia, Chronic
  • 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
Experimental: GDC-0199 (ABT-199) Arm
Interventions:
  • Drug: GDC-0199 (ABT-199)
  • Drug: bendamustine
  • Drug: rituximab [MabThera/Rituxan]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
November 2016
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: GO28440 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   France,   Germany
 
NCT01671904
GO28440, 2012-002351-42
Not Provided
Genentech, Inc.
Genentech, Inc.
AbbVie (prior sponsor, Abbott)
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP