Study Summary
This trial is testing a new cancer treatment combining a new drug with standard chemotherapy, to see if it improves remission rates in patients with a certain type of lymphoma.
Eligible Conditions
- Mantle Cell Lymphoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Baseline to end of study (up to 2 years)
Week 2
Complete response (CR) rate by PET/CT scan using Lugano Classification for Malignant Lymphoma
Week 18
Adverse events of acalabrutinib and R-CHOP by using CTCAE version 5.0
Year 2
Changes in scores of partient reported outcomes (PRO) as measured by EORTC QLQ-C30
Changes in scores of partient reported outcomes (PRO) as measured by FACT-Cog
Changes in scores of partient reported outcomes (PRO) as measured by FACT-Lym
Event-free in patients who discontinue acalabrutinib at the point of MRD negativity prior to transplant by flow cytometry
Measures of efficacy by using the RECIL 2017 criteria.
Overall survival in patients who discontinue acalabrutinib at the point of MRD negativity
Up to 18 weeks
Rate of minimal residual disease negativity (MRD) prior to transplant by flow cytometry
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Acalabrutinib with R-CHOP chemotherapy
1 of 1
Experimental Treatment
54 Total Participants · 1 Treatment Group
Primary Treatment: R-CHOP chemotherapy · No Placebo Group · Phase 2
Acalabrutinib with R-CHOP chemotherapyExperimental Group · 2 Interventions: R-CHOP chemotherapy, Acalabrutinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to end of study (up to 2 years)
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,380 Previous Clinical Trials
473,385 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a histologic diagnosis of MCL according to the World Health Organization classification.
A mass with a longest diameter ≥1.5 cm or a mass with a longest diameter ≥1.0 cm.
You are willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
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Conditions
Cancer Related
Treatments