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Chronic Lymphoid Leukemia (CLL)

BMS-986016 for Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas
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
Status Conditions Phase Study ID
Pending Hematologic Neoplasms Phase I NCT02061761
Summary

The purpose of this study is to characterize the safety, tolerability, dose limiting toxicities and maximum tolerated dose of BMS-986016 administered to subjects with relapsed or refractory chronic lymphocytic leukemia and lymphomas.


Investigator
Ajay K. Gopal, MD
Location    
SCCA Phase 1 Program Office 206-288-7551 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • Part A:
    • Chronic Lymphocytic Leukemia
    • Hodgkin Lymphoma
    • Non Hodgkin Lymphoma
  • Part B:
    • Chronic Lymphocytic Leukemia
    • Hodgkin Lymphoma
    • Diffuse Large B-cell Lymphoma
    • Mantle Cell Lymphoma
  • Progressed, or been refractory to at least one prior standard therapy, including radiation, immunotherapy, cytotoxic chemotherapy, and select antibody (anti-CD20, Alemtuzumab, or Brentuximab) therapy
  • Not eligible for or declined transplantation or any standard therapy known to be life prolonging or life saving
  • Subjects without prior exposure to immune cell modulating antibody regimens such as anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death protein 1 (PD-1), anti-programmed cell death protein ligand 1 (PD-L1), anti-PD-L2, anti-KIR, anti-CD137, or anti-OX40 antibodies. Prior anti-CD20, Alemtuzumab or Brentuximab antibody therapy is allowed
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • At least 1 lesion with measurable disease
  • Willing to consent to allow a pre-treatment bone marrow biopsy
  • Willing to consent to a pre-treatment tumor biopsy or allow the acquisition of an existing tumor sample
Exclusions (conditions that would prevent participation in this study)
  • Primary cutaneous lymphoma, lymphoproliferative diseases associated with primary immune deficiencies, and lymphomas associated with human immunodeficiency virus (HIV) infection
  • Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease (controlled CNS metastases are allowed)
  • Autoimmune disease
Last Updated
July 07, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.