NCT04872413

Interrogating Biological Signaling Pathway Dysregulations and In Vitro Screening With Personalized Therapies in Relapsed or Refractory Mantle Cell Lymphoma, MCL MATCH Trial

A Pilot Study of Interrogating Biological Signaling Pathway Dysregulations and In Vitro Screening With Personalized Therapies in Resistant Mantle Cell Lymphoma (MCL) - the MCL MATCH Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial collects and tests samples using genetic testing to find personalized treatments that may work best for patients with mantle cell lymphoma (MCL) that has come back (relapsed) or does not respond to treatment (refractory). Several types of MCL are difficult to treat due to specific genetic changes (mutations or alterations in the DNA/RNA expression in the cells) that make them not respond to a certain type of drug called a Bruton's tyrosine kinase (BTK) inhibitor. The goal of this clinical research study is to use genetic testing to identify which drugs may be most effective in treating patients with MCL who have this type of genetic mutation.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the feasibility of the proposed therapy based on dysregulated cell signaling pathways in combination with in vitro drug activity. SECONDARY OBJECTIVES: I. Overall response rates (complete response \[CR\] + partial response \[PR\]). II. Safety in patients who were treated with matched personalized therapies. III. Duration of response. IV. Progression free survival (PFS). V. Overall survival (OS). EXPLORATORY OBJECTIVE: I. Correlation of somatic mutations in MCL with cell signaling dysregulated activity and therapeutic implications of somatic mutations in relapsed MCL. OUTLINE: Patients undergo blood, saliva or tissue sample collection for messenger ribonucleic acid analysis (mRNA) analysis and drug efficacy testing. Patients assigned treatment per the results are followed every 1 cycle of therapy for 1 year, every 2 months for 1 year, every 4 months for 1 year then every 6 months thereafter.

Conditions

• Recurrent Mantle Cell Lymphoma
• Refractory Mantle Cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood, saliva or tissue sample collection
OTHER	Follow-Up	Undergo follow-up

Timeline

• Start date: 2021-03-04
• Primary completion: 2025-02-21
• Completion: 2025-02-21
• First posted: 2021-05-04
• Last updated: 2025-02-26

Locations

1 site across 1 country: United States