A Study of the Safety and Drug/Body Interactions of LAM-002A for Patients with Non-Hodgkin's Lymphoma

Overview

About this study

The purpose of this study is to evaluate the safety, tolerability, drug/body interactions, and preliminary activity of LAM-002A for the treatment of patients who have B-cell non-Hodgkin's lymphoma that has returned or is resistant to treatment. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Able to understand and comply with the protocol requirements and has signed the informed consent document
  • Confirmed diagnosis of B-cell Non-Hodgkin's lymphoma limited to follicular lymphoma, DLBCL, mantle cell lymphoma, marginal zone lymphoma, or CLL/SLL that has progressed and for which standard curative measures do not exist or are no longer effective
    • Prior therapy must have included a rituximab-based regimen
  • DLBCL must have progressed after transplant, or unwilling, unable or not an appropriate candidate for an autologous stem cell transplant
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
  • Adequate organ and marrow function
  • Able to swallow oral capsules without difficulty
  • Using acceptable birth control
  • Women of childbearing potential must have a negative serum or urine pregnancy test at screening

Exclusion Criteria

  • Central nervous system (CNS) lymphoma is not eligible for the trial unless the disease had been treated and remains without symptoms with no active CNS lymphoma
  • Not recovered from toxicity due to all prior therapies
  • Other uncontrolled significant illness
  • History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of apilimod
  • Has undergone major surgery within 28 days prior to first dose of study drug
  • Past history of tuberculosis (TB) or active infection with TB, human immunodeficiency virus (HIV), hepatitis B or hepatitis C
  • Is lactating and breast feeding
  • Unable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee
  • This is a shortened list and additional criteria may apply

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Taimur Sher, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Ansell, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions