Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma or CLL

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01775631
First received: January 23, 2013
Last updated: July 23, 2014
Last verified: February 2014

January 23, 2013
July 23, 2014
March 2013
February 2017   (final data collection date for primary outcome measure)
  • Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities [ Time Frame: Up to 60 days after last dose of Urelumab ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of Urelumab in combination with Rituximab as measured by incidence of adverse events (AEs), serious AEs, death, vital sign changes, electrocardiograms (ECGs), physical examination results, and laboratory test abnormalities [ Time Frame: Up to 110 days after last dose of Rituximab ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01775631 on ClinicalTrials.gov Archive Site
  • Efficacy-Antitumor Activity of Urelumab in combination with Rituximab as measured by best overall response, progression-free survival, time to response, and duration of response [ Time Frame: Up to approximately 2 years ] [ Designated as safety issue: No ]
  • Maximum observed serum concentration (Cmax) of Urelumab and Rituximab [ Time Frame: 15 time points up to Day 60 of Follow-up ] [ Designated as safety issue: No ]
  • Time of maximum observed serum concentration (Tmax) of Urelumab [ Time Frame: 15 time points up to Day 60 of Follow-up ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of Urelumab [ Time Frame: 15 time points up to Day 60 of Follow-up ] [ Designated as safety issue: No ]
  • Trough observed serum concentration (Cmin) of Urelumab and Rituximab [ Time Frame: 15 time points up to Day 60 of Follow-up ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Urelumab [ Time Frame: 15 time points up to Day 60 of Follow-up ] [ Designated as safety issue: No ]
  • Immunogenicity of Urelumab in combination with Rituximab as determined by blood sample measurements of anti-drug antibodies (ADA) [ Time Frame: Up to approximately 2.33 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma or CLL
A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies

The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab in combination with Rituximab in patients with B-cell Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia (CLL)

Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
B-Cell Malignancies
  • Biological: Urelumab
    Other Name: BMS-663513
  • Biological: Rituxan
    Other Name: Rituximab
  • Experimental: Arm 1 - Urelumab (0.1 mg/kg) + Rituxan (375 mg/m2)

    Urelumab (BMS-663513) 0.1 mg/kg intravenous infusion every 3 weeks up to 2 years, depending on response and tolerability to study drug.

    Rituxan (Rituximab) 375 mg/m2 intravenous infusion 4 weekly doses every 12 weeks up to 2 years, depending on response and tolerability to study drug

    Interventions:
    • Biological: Urelumab
    • Biological: Rituxan
  • Experimental: Arm 2 - Urelumab (0.3 mg/kg) + Rituxan (375 mg/m2)

    Urelumab (BMS-663513) 0.3 mg/kg intravenous infusion every 3 weeks up to 2 years, depending on response and tolerability to study drug.

    Rituxan (Rituximab) 375 mg/m2 intravenous infusion 4 weekly doses every 12 weeks up to 2 years, depending on response and tolerability to study drug

    Interventions:
    • Biological: Urelumab
    • Biological: Rituxan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
138
February 2017
February 2017   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Clinical diagnosis of relapsed/refractory B-cell Malignancies per International Workshop Group (IWG) 2007 criteria or 2008 International Workshop on CLL (IWCLL) criteria
  • Progressed or refractory to at least 1 prior line of standard therapy
  • Subjects in Expansion cohorts are restricted to relapsed/refractory Chronic Lymphocytic Leukemia (CLL), diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are refractory to rituximab. Rituximab refractoriness is defined as progression during treatment on prior rituximab therapy or rituximab containing regimen or progression within 6 months from last received dose of rituximab
  • Follicular Lymphoma (FL) must have at least 1 lesion that can be biopsied at screening and on treatment
  • Eastern Cooperative Oncology Group (ECOG) of 0 to 1

Exclusion Criteria:

  • Active or progressing brain metastases
  • Other concomitant malignancies (with some exceptions per protocol)
  • Active or history of autoimmune disease
  • Positive test for human immunodeficiency virus (HIV) 1&2 or known Acquired immune deficiency syndrome (AIDS)
  • History of any hepatitis (A, B or C)
  • History of grade 3-4 drug-related hepatitis
  • Known current drug or alcohol abuse
  • Active tuberculosis (TB)
  • Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR). However, Anti-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1) are permissible as prior therapy.
Both
18 Years and older
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States
 
NCT01775631
CA186-017
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2014

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