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Bruton's Tyrosine Kinase (BTK) Inhibitor

PCI-32765 for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By Inhye Ahn, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Any prior therapy with PCI 32765 or any other BTK inhibitors
Requires anticoagulation with warfarin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment drug, PCI-32765, to see if it can treat chronic lymphocytic leukemia and small lymphocytic lymphoma in elderly people and people with 17p deletion.

Who is the study for?
This trial is for adults with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. It's specifically for those over 65, or at least 18 with a genetic abnormality called 17p deletion. Participants must be able to swallow capsules and agree to use contraception if they can have children.
What is being tested?
The trial tests PCI-32765, a new drug for treating CLL/SLL in older patients and those with the 17p deletion who often don't do well on standard treatments. Patients take daily capsules for six cycles and may continue if beneficial without severe side effects.
What are the potential side effects?
While not explicitly listed, potential side effects of PCI-32765 could include typical reactions to cancer medications such as nausea, fatigue, blood count changes, liver or kidney function issues based on exclusion criteria related to organ functions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never taken PCI 32765 or any BTK inhibitors.
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I need to take warfarin for blood thinning.
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I understand the study's purpose and can give informed consent.
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I am under 18 years old.
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I haven't had any CLL treatments like chemotherapy in the last 4 weeks.
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I am HIV positive.
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My CLL has transformed into a more aggressive form.
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I have an autoimmune blood disorder treated with steroids.
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My liver function tests are higher than normal, but it's not because of Gilbert's disease or liver infiltration.
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My kidney function is reduced with high creatinine or low GFR.
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I am not currently on high-dose steroids or undergoing cancer treatments.
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I have an active Hepatitis B infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate at 6 Months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Elderly greater than 65Experimental Treatment1 Intervention
Group II: 17p DeletioinExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,934 Previous Clinical Trials
47,792,190 Total Patients Enrolled
90 Trials studying Leukemia
10,847 Patients Enrolled for Leukemia
Inhye Ahn, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
2 Previous Clinical Trials
61 Total Patients Enrolled
2 Trials studying Leukemia
61 Patients Enrolled for Leukemia
Andy Itsara, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Leukemia
29 Patients Enrolled for Leukemia

Media Library

PCI-32765 (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01500733 — Phase 2
Leukemia Research Study Groups: Elderly greater than 65, 17p Deletioin
Leukemia Clinical Trial 2023: PCI-32765 Highlights & Side Effects. Trial Name: NCT01500733 — Phase 2
PCI-32765 (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01500733 — Phase 2
~6 spots leftby Nov 2025
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