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Bruton's Tyrosine Kinase (BTK) Inhibitor
Acalabrutinib for Mantle Cell Lymphoma
Phase 2
Recruiting
Led By Preetesh Jain
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- 1 or more grade 3 neutropenia with infection or fever; OR,
Creatinine (Cr) clearance minimum to 30 mL/min per the Cockcroft-Gault formula as acalabrutinib pharmacokinetic (PK) has not been evaluated in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 29 mL/min/1.7 3^m2, MDRD) or renal impairment requiring dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial studies the effects of acalabrutinib on patients with mantle cell lymphoma who cannot tolerate ibrutinib.
Who is the study for?
This trial is for patients with mantle cell lymphoma who had adverse reactions to ibrutinib. They must have resolved toxicities, acceptable blood counts, organ function within certain limits, no history of certain BTK mutations or progressive disease on ibrutinib, and not be pregnant or breastfeeding. Eligible participants should also agree to use effective contraception.Check my eligibility
What is being tested?
The study tests acalabrutinib's effectiveness in treating mantle cell lymphoma in patients intolerant to ibrutinib. It examines whether acalabrutinib can halt cancer growth by inhibiting enzymes necessary for the proliferation of cancer cells.See study design
What are the potential side effects?
Potential side effects include bleeding risks, heart rhythm problems, infections due to immune system suppression, liver enzyme changes indicating potential liver damage, and other common chemotherapy-related side effects like fatigue and digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had severe low white blood cell counts with fever or infection.
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My kidneys work well enough (Cr clearance over 30 mL/min).
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My lymphoma is CD20 positive with specific genetic features.
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I have experienced severe side effects from treatment.
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My treatment was stopped due to severe blood-related side effects, not cancer progression.
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I can do most of my daily activities on my own.
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I stopped taking ibrutinib for reasons other than my cancer getting worse.
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I have two or more serious side effects not related to my blood.
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My treatment was stopped due to severe blood-related side effects, not because my condition worsened.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (complete response + partial response)
Secondary outcome measures
Incidence of adverse events
Overall survival
Progression free survival
Side effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC
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 36 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,484 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,334 Total Patients Enrolled
Preetesh JainPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have experienced severe side effects from treatment.I have a heart condition.My blood counts meet the required levels despite having MCL in my bone marrow.I have had severe low white blood cell counts with fever or infection.My kidneys work well enough (Cr clearance over 30 mL/min).I need treatment for my condition now, not just monitoring.My blood pressure is not well-controlled.I have a tumor that can be measured and is larger than 1.5 cm.I am taking more than 10 mg of prednisone or its equivalent daily.I have not had a heart attack in the last 6 months.My lymphoma is CD20 positive with specific genetic features.I am cancer-free except for minor skin cancers or cancers in remission with a life expectancy over 3 years.You have read and agreed to sign a form that explains the study and your participation in it, approved by the Institutional Review Board.My liver function tests are within the required range.I am using or willing to use effective birth control during and after treatment.My heart condition severely limits my daily activities.I was not initially given ibrutinib due to concerns about my other health issues but have now been cleared by a cardiologist.I need medication for stomach acid, like omeprazole.I have had hepatitis B vaccination or natural immunity, and if I have hepatitis C, it is not active.My heart rate is often below 50 beats per minute.I have experienced severe side effects from treatment.I have low blood pressure.I haven't had any recent bleeding disorders or strokes.You have a serious medical condition, such as uncontrolled diabetes, COPD, or kidney problems, that the doctor believes could make participating in the study too risky. You also have a psychiatric illness or difficult social circumstances that could make it hard for you to follow the study's rules or sign the consent form.I have not progressed or had an allergic reaction while on ibrutinib therapy.I have uncontrolled AIHA or ITP.I have not had major surgery in the last 4 weeks.I do not have any major stomach or bowel problems that could affect medication absorption.I haven't taken antibiotics or antivirals in the last 14 days.My treatment was stopped due to severe blood-related side effects, not cancer progression.I have active heart disease symptoms.I have been treated with acalabrutinib before.I can do most of my daily activities on my own.I need medication that strongly affects liver enzymes.I have side effects from previous ibrutinib treatment, but not blood-related issues.My white blood cell and platelet counts meet the study's requirements despite my bone marrow condition.Your absolute neutrophil count (ANC) should be higher than 1000 cells per cubic millimeter.I have been diagnosed with sick sinus syndrome.I stopped taking ibrutinib for reasons other than my cancer getting worse.I cannot tolerate Ibrutinib due to severe side effects despite receiving care.I have experienced rapid heartbeats originating from my ventricles.I have two or more serious side effects not related to my blood.My treatment was stopped due to severe blood-related side effects, not because my condition worsened.My cancer has mutations making it resistant to certain treatments.I do not have brain involvement with my lymphoma or a condition called PML.I need to take warfarin or a similar medication to prevent blood clots.Any side effects I had from previous treatments are mild now.I often feel dizzy or faint.I have ongoing and uncontrolled irregular heartbeats.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (acalabrutinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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