NCT04660045

Early Intervention With Acalabrutinib in Patients With High Risk CLL

A Phase II Trial of Early Intervention With Acalabrutinib in Patients With CLL at High Risk for Richter's Transformation

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of acalabrutinib treatment in patients with chronic lymphocytic leukemia (CLL) deemed at high risk for Richter's Transformation (RT). This is a single arm study. Enrolled patients will initiate therapy with acalabrutinib and will dose continuously. While on study, subjects will be monitored monthly for the first 3 months, then every three months thereafter until disease progression, discontinuation due to toxicity, death, or study completion.

Detailed description

This is a multi-center, single arm, Phase II clinical trial to investigate the effectiveness of acalabrutinib treatment within 6 months of chronic lymphocytic leukemia (CLL) diagnosis for patients with CLL deemed at high risk for Richter's Transformation (RT).

Conditions

• Chronic Lymphocytic Leukemia
• CLL/SLL

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Acalabrutinib, oral, 100 mg BID, continuous

Timeline

• Start date: 2022-05-01
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2020-12-09
• Last updated: 2022-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study