Tag: LAM-002A

LAM-002A: What You Should Know about this Agent for B-cell Non-Hodgkin Lymphoma

What is LAM-002A?  

LAM-002A is an oral selective kinase inhibitor currently undergoing Phase I trials for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma. These trials seek to evaluate the safety, tolerability, and pharmacokinetics of LAM-002A. Before investigation of LAM-002A in patients with lymphoma, it was studied and found to be safe in patients with psoriasis, rheumatoid arthritis (RA) and Crohn’s disease.

How does LAM-002 work?

Also known as apilimod dimesylate, LAM-002 is a potent and highly selective PIKfyve kinase inhibitor. It is the first compound in this class.  Kinases are proteins that modify cell functions. Lymphomas can arise from overactive or high levels of kinases. LAM-002 disrupts the normal activity of this particular kinase, which can lead to death of cancer cells.

What are the side effects?

In previous studies of patients with psoriasis, RA and Crohn’s disease, LAM-002 was well tolerated, with most side effects assessed as mild in severity. The most frequent side effects included headaches, upper respiratory tract infection, and nausea. To date all available nonclinical and clinical data support the safety profile of LAM-002A in patients with non-Hodgkin lymphoma.

How can you access LAM-002A?

LAM-002A is available through a recently opened Phase I trial for men and women with previously-treated B-cell non-Hodgkin lymphoma in the Lymphoma Program at Weill Cornell Medicine.

A full list of trials open at WCM for patients with non-Hodgkin lymphoma is available on our Joint Clinical Trials website.

New Clinical Trial: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of LAM-002A Administered Orally in Subjects with Relapsed or Refractory B-cell non-Hodgkin Lymphoma

The Weill Cornell Medicine Lymphoma Program has recently opened a new clinical trial for men and women with previously-treated B-cell non-Hodgkin lymphoma. (B-cell NHL) The study sponsor is LAM Therapeutics, and the principal investigator at Weill Cornell is Sarah Rutherford, M.D.. For more information about the study, please call Rita Gazivoda, RN at 212-746-0702 or e-mail Rita at rig9021@med.cornell.edu.

Study Summary

This clinical trial is for men and women with B-cell non-Hodgkin lymphoma (B-cell NHL) who were previously treated for this disease.

Management of patients with non-Hodgkin lymphoma varies widely depending on histology. Patients with DLBCL who relapse after, or who are not candidates for ASCT, as well as patients with relapsed mantle cell lymphoma, marginal zone lymphoma, follicular lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are not considered curative with conventional therapies. Therefore management of relapsed and refractory NHL remains an unmet medical need.

This is a Phase 1, single-arm, open-label dose-escalation study of the safety and pharmacokinetics of LAM-002A administered orally in subjects with relapsed or refractory B-cell NHL. There will be a dose-escalation stage and an expansion stage for this study. The study drug will be administered on a twice daily oral dosing regimen with a cycle length of 28 days. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. All patients will be followed for overall survival every three months via telephone contact during the post-treatment follow-up period.

Key Eligibility

  • Men and women age 18 and older with histologically confirmed diagnosis of B-cell NHL limited to follicular lymphoma, DLBCL, mantle cell lymphoma, marginal zone lymphoma, or CLL/SLL.
  • Prior therapy must have included a rituximab-based chemo-immunotherapy regimen.
  • Detailed eligibility reviewed when you contact the study team.
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