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Acalabrutinib for Mantle Cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mantle Cell LymphomaAcalabrutinib - Drug
Eligibility
65+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a combination of two drugs may help treat mantle cell lymphoma in elderly patients.

Eligible Conditions
  • Mantle Cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Cohort 2 (Co-trial cohort)
1
Acalabrutinib
1
Acalabrutinib

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 7 years

At 16 weeks
Complete remission rate
Year 7
Overall survival (OS)
Year 7
Progression free survival (PFS)
Day 30
Incidence of adverse events (AEs)
Up to 7 years
Overall response rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Cohort 2 (Co-trial cohort)
1
Acalabrutinib
1
Acalabrutinib

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

1 Treatment Group

Treatment (acalabrutinib, rituximab)
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Acalabrutinib · No Placebo Group · Phase 2

Treatment (acalabrutinib, rituximab)Experimental Group · 2 Interventions: Acalabrutinib, Rituximab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 7 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,802 Previous Clinical Trials
1,788,849 Total Patients Enrolled
Luhua (Michael) WangPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
628 Total Patients Enrolled

Eligibility Criteria

Age 65+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Ki-67%<=50% in involved tissues.
You have an Eastern Cooperative Oncology Group performance status of 2 or less.
You have an absolute neutrophil count (ANC) > 1,000/mm3 and platelet count >100,000/mm3.
References

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