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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Non-Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Craig Moskowitz, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women ≥ 18 years of age.
Patients must have histologic confirmation of relapsed or refractory lymphoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks (end of cycle 3)
Awards & highlights

Study Summary

This trial is testing a new combination treatment to see if it can improve responses and cure some patients.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Leukemia
  • Marginal Zone Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks (end of cycle 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks (end of cycle 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Complete Response (CR)
Secondary outcome measures
Event-Free Survival (EFS)
Number of Treatment-Emergent Adverse Events
Overall Survival (OS)
+4 more

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: Acalabrutinib + R-ICEExperimental Treatment5 Interventions
Acalabrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (R-ICE). All participants will receive combination treatment for 3 cycles. Each cycle lasts 21 consecutive days. Combination treatment includes twice daily dose of Acalabrutinib, Rituximab on Day 1 of each cycle, Ifosfamide and Carboplatin on Day 2 of each cycle, and Etoposide on Days 1-3 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Ifosfamide
FDA approved
Acalabrutinib
FDA approved
Rituximab
FDA approved
Etoposide
FDA approved

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
898 Previous Clinical Trials
409,649 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,253 Previous Clinical Trials
288,538,181 Total Patients Enrolled
Craig Moskowitz, MDPrincipal Investigator - University of Miami
Wayne State University School Of Medicine (Medical School)
Mem Sloan-Kettering Cancer Center (Residency)
12 Previous Clinical Trials
471 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 in Combination With R-ICE For Relapsed or Refractory Lymphoma
Craig Moskowitz 2020. "Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04189952.
~0 spots leftby Apr 2025
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