NCT05583149

Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas

A Phase 2 Study of Acalabrutinib in Combination With Lisocabtagene Maraleucel in Relapsed/Refractory Aggressive B-cell Lymphomas

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Patrick C. Johnson, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to assess the effectiveness and safety of acalabrutinib combined with lisocabtagene maraleucel (liso-cel) for people with relapsed/refractory aggressive B-cell lymphoma. This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleuce

Detailed description

This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleucel. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. \- Participants will receive one infusion of liso-cel and will receive acalabrutinib capsules twice daily as long as treatment is tolerated and disease does not worsen (disease progression) for up to one year. Participants will be followed by clinical visits for up to 5 years and the medical record will be monitored for up to 15 years. It is expected that about 27 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved acalabrutinib for this specific disease, but it has been approved for other uses. The U.S. FDA has approved lisocabtagene maraleucel for this specific disease. AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and supplying acalabrutinib.

Conditions

• Refractory Aggressive B-cell Lymphomas
• Refractory B-Cell Non-Hodgkin Lymphoma
• Aggressive B-cell NHL
• Diffuse Large B-cell Lymphoma (DLBCL)
• De Novo or Transformed Indolent B-cell Lymphoma
• DLBCL, Nos Genetic Subtypes
• T Cell/Histiocyte-rich Large B-cell Lymphoma
• EBV-Positive DLBCL, Nos
• Primary Mediastinal [Thymic] Large B-cell Lymphoma (PMBCL)
• High-Grade B-Cell Lymphoma, Nos
• C-MYC/BCL6 Double-Hit High-Grade B-Cell Lymphoma
• Grade 3b Follicular Lymphoma
• C-MYC/BCL2 Double-Hit High-Grade B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	ACALABRUTINIB	Oral, twice daily, timing and dosage per protocol
DRUG	LISOCABTAGENE MARALEUCEL	via IV timings and dosage per protocol
DRUG	Lymphodepleting chemotherapy	lymphodepleting chemotherapy with cyclophosphamide and fludarabine once a day for 3 days via IV about 2-4 hours. This will occur only once prior to lisocabtagene maraleucel infusion.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-11-23
• Completion: 2029-03-01
• First posted: 2022-10-17
• Last updated: 2026-01-29
• Results posted: 2026-01-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study