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Bruton Tyrosine Kinase Inhibitor

Acalabrutinib for Splenic Marginal Zone Lymphoma

Phase 1
Waitlist Available
Led By Narendranath Epperla, MD
Research Sponsored by Narendranath Epperla
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first dose to documented disease progression, or death from any cause, whichever occurs first, assessed at 2 years
Awards & highlights

Study Summary

This study is evaluating whether a combination of two drugs may be more effective than either drug alone for treating patients with indolent non-Hodgkin lymphoma.

Eligible Conditions
  • Splenic Marginal Zone Lymphoma
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first dose to documented disease progression, or death from any cause, whichever occurs first, assessed at 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first dose to documented disease progression, or death from any cause, whichever occurs first, assessed at 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Overall response rate (ORR) (assessed by computed tomography)
Secondary outcome measures
Positron-Emission Tomography
Duration of response (DOR)
Patient reported outcomes (PROs)
+1 more
Other outcome measures
Biomarker analyses
Pharmacokinetics analyses

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
2%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (acalabrutinib, duvelisib)Experimental Treatment2 Interventions
Patients receive acalabrutinib PO BID, and duvelisib PO BID on days 1-28. Treatment repeats every 28 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 19, patients receive acalabrutinib PO BID for up to 60 months in absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2030
Duvelisib
2016
Completed Phase 3
~760

Find a Location

Who is running the clinical trial?

Narendranath EpperlaLead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Narendranath Epperla, MDPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Narendranath Epperla 2022. "Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04836832.
~0 spots leftby Apr 2025
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