Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma or CLL
This study is currently recruiting participants.
Verified April 2013 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01775631
First received: January 23, 2013
Last updated: April 18, 2013
Last verified: April 2013
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
B-Cell Malignancies |
Biological: Urelumab Biological: Rituxan |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 104 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Biological: Urelumab
Other Name: BMS-663513
Biological: Rituxan
Other Name: Rituximab
|
|
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 |
Biological: Urelumab
Other Name: BMS-663513
Biological: Rituxan
Other Name: Rituximab
|
Detailed Description:
Intervention model: Dose Escalation (part 1) of study= Sequential Design; Dose Expansion (part 2) of study= Parallel Design
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
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
- Follicular Lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) patients must have at least 1 lesion that can be biopsied at screening and on treatment
- Men and women 18 and older
- Women of childbearing potential (WOCBP) and men must use highly effective methods of contraception
- Eastern Cooperative Oncology Group (ECOG) of 0 to 1
- Progressed or refractory to at least 1 prior line of standard therapy; for dose expansion cohort a maximum of 4 lines of cytotoxic chemotherapy-containing regimens
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 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-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1), anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775631
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Locations
| United States, California | |
| Local Institution | Not yet recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Site 0011 | |
| Local Institution | Not yet recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Site 0001 | |
| United States, Florida | |
| University Of Miami Sylvester Comprehensive Cancer Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Izidore Lossos, Site 0012 305-243-4909 | |
| Local Institution | Not yet recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Site 0003 | |
| United States, Iowa | |
| Local Institution | Not yet recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Site 0004 | |
| United States, Michigan | |
| Local Institution | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Site 0006 | |
| United States, New York | |
| Local Institution | Not yet recruiting |
| New York, New York, United States, 10065 | |
| Contact: Site 0010 | |
| United States, Oregon | |
| Portland Providence Medical Center | Recruiting |
| Portland, Oregon, United States, 97213 | |
| Contact: John Godwin, Site 0002 503-215-5696 | |
| United States, Virginia | |
| Local Institution | Not yet recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Site 0009 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01775631 History of Changes |
| Other Study ID Numbers: | CA186-017 |
| Study First Received: | January 23, 2013 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013