Acalabrutinib for Primary Central Nervous System Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Primary Central Nervous System Lymphoma+1 MoreAcalabrutinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of two different types of drugs to treat people with primary central nervous system lymphoma, a cancer of the lymph nodes in the brain and spinal cord. The study has enrolled three patients so far, but all three had a different type of CNS lymphoma (secondary, not primary) and they all progressed quickly despite treatment. So the study is being amended to only include patients with primary CNS lymphoma.

Eligible Conditions
  • Primary Central Nervous System Lymphoma
  • Secondary Central Nervous System Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Completion of first 12 weeks of treatment within phase I portion of study (estimated to be 14 months)

Month 14
Safe and tolerable dose of regimen
Year 2
Duration of response
Progression-free survival (PFS)
Month 6
Overall response rate (complete response (CR) + partial response (PR))
Time to response
Year 5
Overall survival (OS)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Acalabrutinib + BSC
12%Headache
2%Pneumonia
2%Respiratory failure
1%Acute kidney injury
1%Bacterial sepsis
1%Mucosal infection
1%Pleural effusion
1%Hypotension
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT04346199) in the Acalabrutinib + BSC ARM group. Side effects include: Headache with 12%, Pneumonia with 2%, Respiratory failure with 2%, Acute kidney injury with 1%, Bacterial sepsis with 1%.

Trial Design

3 Treatment Groups

Phase I Dose Level 1: Durvalumab + Acalabruitinib
1 of 3
Phase I Dose Level 2: Durvalumab + Acalabruitinib
1 of 3
Expansion Cohort: Durvalumab + Acalabrutinib
1 of 3

Experimental Treatment

21 Total Participants · 3 Treatment Groups

Primary Treatment: Acalabrutinib · No Placebo Group · Phase 1

Phase I Dose Level 1: Durvalumab + AcalabruitinibExperimental Group · 2 Interventions: Acalabrutinib, Durvalumab · Intervention Types: Drug, Drug
Phase I Dose Level 2: Durvalumab + AcalabruitinibExperimental Group · 2 Interventions: Acalabrutinib, Durvalumab · Intervention Types: Drug, Drug
Expansion Cohort: Durvalumab + AcalabrutinibExperimental Group · 2 Interventions: Acalabrutinib, Durvalumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: completion of first 12 weeks of treatment within phase i portion of study (estimated to be 14 months)

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,803 Previous Clinical Trials
2,279,428 Total Patients Enrolled
AstraZenecaIndustry Sponsor
3,989 Previous Clinical Trials
91,527,813 Total Patients Enrolled
Neha Mehta-Shah, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
68 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
ALT and AST ≤ 2.5 times the upper limit of normal.
Patients with vitreous involvement alone are not eligible.
The absolute neutrophil count (ANC) is greater than 1.0 x 109/L.
You have a prolonged prothrombin time, partial thromboplastin time, or international normalized ratio.