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A Multi-Center Phase 2 Study of Acalabrutinib-Lenalidomide-Rituximab with Real-time MRD Monitoring in Patients with Untreated Mantle Cell Lymphoma

Clinical Trial Details

This clinical trial is for men and women age 18 and older with mantle cell lymphoma (MCL) to check efficacy and safety of the combination of acalabrutinib, lenalidomide and rituximab (ALR) in previously untreated mantle cell lymphoma. 

Mantle cell lymphoma is a type of cancer that the body makes abnormal B-cells (white blood cells) responsible for fighting infections. Mantle cell lymphoma is incurable, with a median survival of 5-7 years. Therefore, there is a need to find more effective treatments with fewer side effects. 

Both lenalidomide-based and acalabrutinib inhibitor-based regimens have demonstrated significant clinical activities in MCL patients. The clinical and non-clinical observations suggest that acalabrutinib-lenalidomide-rituximab combined therapy may produce superior antitumor activity compared to one drug alone. 

This is a single arm study. Patients will take medication orally and intravenous (IV). Cycles will be 1-12, 1 cycle = 28 days. 

All patients will be followed for survival until end of study or until sponsor ends the study. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Key Eligibility: 
  • Open to men and women 18 years and older 
  • Pathologically confirmed mantle cell lymphoma 
  • No prior systemic therapy for lymphoma 
  • Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1807019439

ClinicalTrials.gov:

NCT03863184

Status

Open to Enrollment

Age Group

Adult

Sponsor