Acalabrutinib for Diffuse Large B-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapsed or refractory disease

Pathologically confirmed de novo ABC DLBCL

Must not have

Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction

Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF < 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the date of disease progression, assessed up to cycle 48 (1 cycle is 28 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial looked at the safety of a new drug, acalabrutinib, in people with a certain type of lymphoma that has come back or does not respond to treatment.

Who is the study for?

This trial is for adults over 18 with a specific type of lymphoma called de novo ABC DLBCL that has come back or hasn't responded to treatment. They must have at least one measurable site of the disease. It's not for those with serious heart issues, pregnant or breastfeeding women, anyone with life-threatening conditions, gastrointestinal disorders, or bowel obstruction.

What is being tested?

The trial is testing Acalabrutinib's safety in patients who have relapsed or are refractory to other treatments for the ABC subtype of Diffuse Large B-Cell Lymphoma (DLBCL).

What are the potential side effects?

While not explicitly listed here, common side effects from drugs like Acalabrutinib may include headaches, diarrhea, muscle and joint pain, reduced blood cell counts leading to increased infection risk and bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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My condition has returned or didn't respond to treatment.

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My cancer is a type of aggressive lymphoma diagnosed for the first time.

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I have at least one tumor that can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects how my stomach or intestines absorb food.

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I do not have serious heart problems like recent heart attacks or severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the date of disease progression, assessed up to cycle 48 (1 cycle is 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the date of disease progression, assessed up to cycle 48 (1 cycle is 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the date of disease progression, assessed up to cycle 48 (1 cycle is 28 days) for reporting.