Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma
NCT04189952 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2025-05-31
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
- DRUG
-
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 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 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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Miami
lead OTHER
Principal Investigators
-
Craig Moskowitz, MD · University of Miami
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-22
- Primary Completion
- 2021-06-30
- Completion
- 2022-03-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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