NCT04189952

Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma

A Phase 2, Open-Label Study of Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Non-Germinal Center Diffuse Large B Cell Lymphoma, Transformed Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia or Transformed Marginal Zone Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test a combination treatment of acalabrutunib when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) to evaluate if it will be able to improve durable responses and cure some patients.

Conditions

• Diffuse Large B Cell Lymphoma
• Chronic Lymphocytic Leukemia
• Small Lymphocytic Leukemia
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Acalabrutinib 100 mg capsules taken by mouth every 12 hours (PO BID), for a total of 2 daily doses on Days 1 to 21 of each cycle.
DRUG	Rituximab	Rituximab 375 mg/m2 administered intravenously (IV) on Day 1 of each cycle.
DRUG	Ifosfamide	Ifosfamide 5g/m2 administered intravenously (IV) over 24 hours on Day 2 of each cycle.
DRUG	Carboplatin	Carboplatin Area Under the Concentration time Curve (AUC) 5 IV administered intravenously (IV) on Day 2 of each cycle.
DRUG	Etoposide	Etoposide 100 mg/m2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle.

Timeline

• Start date: 2020-09-22
• Primary completion: 2021-06-30
• Completion: 2022-03-01
• First posted: 2019-12-06
• Last updated: 2025-05-31
• Results posted: 2022-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study