NCT04722172

A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL

A Phase 2 Time Limited Approach Based on Depth of Response to Front-Line Acalabrutinib in Combination With Obinutuzumab for CLL/SLL Patients Who Achieve Complete Remission or Partial Remission With Undetectable Minimal Residual Disease

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety of limiting treatment time with acalabrutinib and obinutuzumab in people who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The researchers want to find out whether stopping the study drugs when the cancer responds to the treatment, followed by a period of observation in which no treatment is given, is better than, the same as, or worse than the usual approach. A usual treatment for CLL and SLL is to give the study drugs continuously until the cancer progresses, even if the disease is in remission. But when people receive these drugs for long periods of time, they can have serious side effects and their cancer can become resistant to treatment.

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Acalabrutinib for a minimum of 13 cycles and maximum 26 cycles.
DRUG	Obinutuzumab	Obinutuzumab will be administered during Cycles 2-7.

Timeline

• Start date: 2021-05-21
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2021-01-25
• Last updated: 2026-04-06

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study