Interested in a Clinical Trial?

Learn More

Lymphoma Clinical Trials

header

SLUHN 2016-101 

A Phase 1b, Open-Label, Dose Escalation Study of ME-401 in Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Follicular Lymphoma (FL)

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Jillian Timer, RN, BSN
    484-503-4156

    Jillian.Timer@sluhn.org

     

     

  • Treatment Agent: ME-401

    Synopsis: The purpose of the study is to investigate an experimental drug called ME-401. ME-401 is being developed by MEI Pharma Inc. (the Sponsor of this study) as a potential treatment for different types of lymphoma and leukemia, which are forms of cancer that affect lymphocytes, immune cells present in the blood, lymph nodes, and other organs. ME-401 is an investigational drug because it is not yet approved by the United States Food and Drug Administration (FDA).

    This study has been designed to look at the safety of ME-401 (also known as the study drug), how your body tolerates the drug, how effective the drug may be and how the drug is taken up by your body when administered orally as a single dose.

      • Diagnosis of relapsed/refractory CLL and/or relapsed/refractory SLL or FL
      • No prior therapy with PI3Kd inhibitors
      • No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was intolerant of BTK therapy
      • QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (ms)
      • For females of childbearing potential, a negative serum pregnancy test within 14 days of study Day 0
    • Known histological transformation from CLL to an aggressive lymphoma
    • Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
    • Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody
    • Positive for hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody
    • Ongoing drug-induced pneumonitis
    • History of clinically significant cardiovascular abnormalities

SLUHN 2017-09 

Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Lauren Downing, BS
    484-526-7936

    lauren.downing@sluhn.org

     

     

  • Treatment Agent: N/A

    Synopsis: The purpose of this study is to gather data on patients like you, who have been diagnosed with classical Hodgkin Lymphoma (cHL).  The study aims to collect information on how treatment for cHL is rendered, as well as assess the outcome of those treatment options.

    • Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
    • Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
    • Patients must be within ± 2 weeks of Day 1 of the first cycle of any line of therapy to enroll; a cycle is practice-defined for chemotherapy, targeted therapy, or immunotherapy-based regimens.
    • Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS)
    • Patients must have available medical records for the date of diagnosis of cHL and available medical records documenting any prior treatment and treatment dates for the Hodgkin lymphoma, including chemotherapy, radiation, surgery and other anti-cancer therapy received.
    • Patients must consent for use of their FFPE tissue blocks for exploratory analyses
    • Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
    • Patients with unknown date of diagnosis of cHL
    • Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
    • Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
    • Patients participating in a clinical study that does not allow enrollment into a non-interventional study
    • Patients enrolled who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up.

    Other protocol defined inclusion/exclusion criteria could apply