Acalabrutinib + ACP-319 for Chronic Lymphocytic Leukemia

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

Men and women ≥ 18 years of age with a confirmed diagnosis of CLL, which has relapsed after, or been refractory to, ≥ 1 previous treatments for CLL; however, subjects with 17p deletion are eligible if they have relapsed after, or been refractory to, 1 prior treatment for CLL.

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Must not have

Grade ≥ 2 toxicity (other than alopecia).

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. after that at cycle 48 and 60 of 28 day cycles.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination treatment for CLL. Early results show it is effective and has few side effects.

Who is the study for?

Adults over 18 with chronic lymphocytic leukemia (CLL) that has come back or didn't respond to at least one treatment can join this trial. Those with certain genetic changes in their CLL may qualify after just one prior treatment. Participants must be able to perform daily activities with relative ease, agree to use birth control, and not have other serious health issues or recent treatments that could affect the study.

What is being tested?

The trial is testing a combination of two drugs, acalabrutinib and ACP-319, for treating CLL. It aims to find out how safe this combo is and how well it works against the disease.

What are the potential side effects?

While specific side effects are not listed here, common ones for cancer treatments like these might include nausea, fatigue, headache, diarrhea, and potential risks related to blood counts and organ function.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 and my CLL has not improved after at least one treatment, or it came back.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I am experiencing side effects from treatment that are moderate to severe, excluding hair loss.

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

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My chronic lymphocytic leukemia has spread to my brain.

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I do not have uncontrolled autoimmune blood disorders.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. after that at cycle 48 and 60 of 28 day cycles.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. after that at cycle 48 and 60 of 28 day cycles.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. after that at cycle 48 and 60 of 28 day cycles. for reporting.