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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Autoimmune Hemolytic Anemia in Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By Alexey Danilov
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anemia (hemoglobin [Hgb] =< 10 g/dL; or Hgb > 10 g/dL dependent on transfusions or maintenance therapy (rituximab, cyclosporin, etc) to maintain this level of hemoglobin, and
Histologically or flow cytometry confirmed diagnosis of CLL/small lymphocytic lymphoma (SLL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after last dose of study drug
Awards & highlights

Study Summary

This trial tests the effect of acalabrutinib on patients with autoimmune hemolytic anemia who have relapsed or who haven't responded to previous treatment. Acalabrutinib may stop cancer cell growth by blocking some of the enzymes needed for cell growth.

Who is the study for?
This trial is for patients with chronic lymphocytic leukemia who have autoimmune hemolytic anemia that hasn't improved or has returned after treatment. Participants must be able to swallow pills, not have severe infections like HIV or hepatitis, and women of childbearing age must use effective birth control. People can't join if they've had certain recent treatments, transplants, uncontrolled infections, significant heart issues, are pregnant/breastfeeding, or can't follow the study plan.Check my eligibility
What is being tested?
The trial is testing acalabrutinib's effectiveness in treating relapsed or refractory autoimmune hemolytic anemia in chronic lymphocytic leukemia patients. It's a phase II study looking at how well acalabrutinib blocks enzymes needed for cancer cell growth.See study design
What are the potential side effects?
Acalabrutinib may cause side effects such as bleeding problems, heart rhythm issues, high blood pressure, headache and diarrhea. Some people might experience muscle pain, fatigue or bruising easily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have anemia or need treatment to keep my hemoglobin above 10 g/dL.
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My diagnosis of CLL or SLL is confirmed by specific lab tests.
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My white blood cell count is healthy or low due to my condition.
Select...
I can swallow pills.
Select...
My CLL has returned or didn't respond to initial treatment with prednisone, with or without rituximab.
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My blood clotting levels are within the normal range, or if I'm on blood thinners, they're at the right level for my treatment.
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My blood clotting time is within the normal range, or if I'm on blood thinners, it's within the therapeutic range.
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My kidney function, measured by creatinine clearance, is adequate.
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I am capable of having children and have not been surgically sterilized.
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I can perform all my self-care but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after last dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Autoimmune hemolytic anemia (AIHA) - overall response rate (ORR)
Secondary outcome measures
Autoimmune hemolytic anemia - overall response rate
Autoimmune hemolytic anemia - specific relapse-free survival (RFS)
Autoimmune hemolytic anemia sustained response
+5 more
Other outcome measures
Percentage of T-cell subsets among study participants

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
12%
Headache
2%
Respiratory failure
2%
Pneumonia
1%
Hypotension
1%
Acute kidney injury
1%
Pleural effusion
1%
Bacterial sepsis
1%
Mucosal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acalabrutinib + BSC
BSC Alone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (acalabrutinib)Experimental Treatment1 Intervention
Patients receive acalabrutinib PO BID on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Treatment with acalabrutinib may be continued beyond 12 cycles for a maximum of 36 cycles if, in the opinion of the treating physician, the patient might benefit from ongoing therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2030

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,448 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,642 Total Patients Enrolled
Alexey DanilovPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
41 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04657094 — Phase 2
Autoimmune Hemolytic Anemia Research Study Groups: Treatment (acalabrutinib)
Autoimmune Hemolytic Anemia Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04657094 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04657094 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the FDA's thoughts on Acalabrutinib?

"Acalabrutinib falls into the Phase 2 category, which means that while there is some evidence to support its safety, none exists yet for its efficacy. Our team at Power gave it a rating of 2."

Answered by AI

Is Acalabrutinib a new or experimental treatment?

"As of this moment, there are 107 independent clinical trials underway that are investigating Acalabrutinib. Of those active trials, 14 have reached Phase 3. The majority of the trials for Acalabrutinib are based in Boston, Massachusetts; however, 8852 different locations across the globe are running tests for this medication."

Answered by AI

Are volunteers still being accepted for this program?

"This specific trial is not recruiting new patients at this time. However, if you are interested in autoimmune hemolytic anemia or Acalabrutinib clinical trials, there are 1821 and 107 studies respectively that are still enrolling candidates."

Answered by AI

How many people are taking lenalidomide in this clinical trial at the most?

"This specific clinical trial is not currently seeking patients, as reflected by an update on 10/7/2022. However, there are 1821 other studies for autoimmune hemolytic anemia and 107 trials for Acalabrutinib that are actively looking for participants."

Answered by AI

What is the main indication for Acalabrutinib?

"Acalabrutinib is most commonly used for treatment of renal dysfunction. It can also be administered to treat various conditions like chronic lymphocytic leukemia (cll), kidney failure, mantle cell lymphoma (mcl)."

Answered by AI

What is the novelty of this research?

"Acalabrutinib was first studied in 2007 by Baxter Healthcare Corporation. After the initial 4640-person Phase 4 trial, the drug received approval and there are now 107 ongoing studies involving Acalabrutinib across 49 countries and 1218 cities."

Answered by AI
~0 spots leftby Mar 2024