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

Overview

Información sobre este estudio

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. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20323758

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