OHSU

IRB #

IRB00010383

Title

A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-Lag-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

Principal Investigator

Stephen Spurgeon

Study Purpose

The purpose of this study is to test the side effects, good and/or bad, and efficacy of the study drug, BMS-986016, on participants and his or her cancer.

Medical Condition(s)

Previously treated Chronic Lymphocytic Leukemia, Non-Hodgkin’s Lymphoma, or Hodgkin’s Lymphoma

Eligibility Criteria

Participants must:
- Consent to pre-treatment bone marrow biopsy and tumor biopsy or access to a sample from a previous tumor biopsy
- have previously treated chronic lymphocytic leukemia, Hodgkin lymphoma, or Non-Hodgkin lymphoma including Diffuse Large B cell Lymphoma, and Mantle cell Lymphoma and are not eligible for a transplant
- be at least 100 days from an autologous transplant
- have adequate organ function as determined by routine blood tests
- have a negative pregnancy test if a woman who is able to become pregnant
- agree to use study approved methods of contraception throughout and after study drug treatment

Participants must not:
- have central nervous system metastases
- have undergone an allogeneic transplant
- require daily supplemental oxygen
- have uncontrolled cardiovascular disease
- have HIV, AIDS, or any chronic hepatitis

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Around 2.5 years including follow up.

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Bristol-Myers Squibb Research and Development

Recruitment End

01/30/2015

Compensation Provided

No


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