A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma

Completed · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin; Leukemia, Chronic Lymphocytic

In brief

This is a Phase 1 dose-exploration study of LAM-002A administered by mouth in patients with relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),and preliminary anti-tumor activity will be evaluated.

Key facts

Study ID

NCT02594384

Run by

OrphAI Therapeutics

People needed

62

Starts

2015-10-01

Expected to finish

2023-03-30

Last updated by the study team

2024-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), primary mediastinal B-cell lymphoma (PMBL), or chronic lymphocytic leukemia/small lymphocytic lymphoma (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.
• Patients with DLBCL: Cancer progression after transplant, or be unwilling, unable or not an appropriate candidate for an autologous stem cell or bone marrow transplant
• Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of 1 or more lesions that measure at least 2.0 cm in the longest dimension (as assessed radiographically)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.
• Adequate organ and marrow function.
• Able to swallow oral capsules without difficulty.
• Acceptable birth control.
• Women of childbearing potential : negative pregnancy test
• Adequate archival or fresh tumor tissue (from biopsy, bone marrow, or peripheral blood) for analysis of potential predictive biomarkers.

You may not qualify if…

• Patients with central nervous system (CNS) lymphoma are not eligible for the trial unless the disease had been treated and the subject 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 LAM-002A
• 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.
• Lactation or 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.

Where it is running

• Clearview Cancer Institute — Huntsville, Alabama, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Winship Cancer Institute at Emory University — Atlanta, Georgia, United States
• Horizon Oncology Research, Inc. — Lafayette, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• New York University School of Medicine — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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