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Bruton's tyrosine kinase (BTK) inhibitor
Venetoclax + Acalabrutinib for Mantle Cell Lymphoma
Phase 2
Recruiting
Led By Luhua (Michael) Wang
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
Age ≥ 18 years at the time of signing the ICF.
Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying how well venetoclax and acalabrutinib work to treat mantle cell lymphoma that didn't respond to previous treatment or has come back.
Who is the study for?
This trial is for adults over 18 with mantle cell lymphoma that has returned or didn't respond to past treatments. Participants must have measurable disease, be able to swallow pills, and have normal organ function tests. Pregnant women, those with HIV or active hepatitis, and individuals who've had certain other cancers or major surgery recently can't join.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: Venetoclax and Acalabrutinib in patients with relapsed/refractory mantle cell lymphoma. Venetoclax aims to block cancer cells' survival mechanisms while Acalabrutinib may halt their growth by inhibiting necessary enzymes.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea, risk of infection due to low blood counts, fatigue, liver problems indicated by abnormal blood tests (AST/ALT), bleeding issues due to interference with clotting pathways (PT/INR), and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take part in all study activities and can swallow pills without trouble.
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I have not had my uterus or both ovaries removed.
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I am able to have children, not pregnant, and will use effective birth control.
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My MCL has returned or didn't respond to at least one treatment and needs more treatment.
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My kidney function is within the required range.
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I am cancer-free except for skin cancer, early-stage cervical or breast cancer, or any cancer in remission for over 3 years.
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My mantle cell lymphoma has returned or resisted treatment, confirmed by a pathologist.
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My bilirubin levels are below 1.5 mg/dl, or high due to specific conditions.
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I agree not to donate sperm during the study.
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I can care for myself and have been stable for the last 2 weeks.
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I have a tumor that can be measured on a CT scan, and it's at least 1.5 cm big.
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I have had a menstrual period in the last 24 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response (CR)
Secondary outcome measures
Duration of response
Event free survival
Incidence of adverse events
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (acalabrutinib, venetoclax)Experimental Treatment2 Interventions
Patients receive acalabrutinib PO BID on days 1-28. Starting cycle 2 day 1, patients also receive venetoclax PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tyrosine
FDA approved
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,752 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,617 Total Patients Enrolled
Luhua (Michael) WangPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
580 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I can take part in all study activities and can swallow pills without trouble.I am HIV positive.I had skin, cervical, or prostate cancer treated with the goal of cure.I need treatment with specific strong medication inhibitors.I have not had my uterus or both ovaries removed.I have no cancer history that could interfere with this study, except for minor cases.I haven't taken strong immune system suppressants or more than 10mg/day of prednisone in the last 28 days.I have a serious brain or spinal cord condition.I have severe digestive issues that could affect medication absorption.I am able to have children, not pregnant, and will use effective birth control.My MCL has returned or didn't respond to at least one treatment and needs more treatment.My kidney function is within the required range.I do not have uncontrolled AIHA or ITP, nor a history of PML.I am cancer-free except for skin cancer, early-stage cervical or breast cancer, or any cancer in remission for over 3 years.I have a bleeding disorder such as von Willebrand's disease or hemophilia.My bilirubin levels are below 1.5 mg/dl, or high due to specific conditions.I do not have any serious infections, including CMV.My mantle cell lymphoma has returned or resisted treatment, confirmed by a pathologist.My condition did not improve with ibrutinib or other BTK inhibitors.I haven't had major surgery in the last 30 days or have fully recovered if I did.I agree not to donate sperm during the study.I can care for myself and have been stable for the last 2 weeks.I have a tumor that can be measured on a CT scan, and it's at least 1.5 cm big.I have had a menstrual period in the last 24 months.I had a different cancer, treated successfully over 3 years ago, with no further treatment needed.I haven't taken acalabrutinib or any experimental drugs recently.I have not received any live vaccines in the last 4 weeks.I need warfarin or a similar medication for blood thinning.I have not had a stroke or brain bleed in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (acalabrutinib, venetoclax)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies in this medical trial for potential participants?
"Affirmative. The details of this clinical trial, initially posted on August 13th 2019, are available for review on the clinicaltrials.gov website and demonstrate that recruiters are actively searching for 50 individuals to participate across 1 site."
Answered by AI
Can you provide any information on the security of Venetoclax usage?
"The safety profile of venetoclax has been rated a 2, as there is ample data to back its level of safety yet none that supports the drug's efficacy."
Answered by AI
Is this particular experimental research unprecedented?
"At the moment, 313 Venetoclax clinical trials are running in 51 nations and 1666 cities. Baxter Healthcare Corporation initiated its first trial for this drug back in 2007 with a total of 4640 participants. The Phase 4 approval stage was achieved soon after that, followed by 113 completed studies since then."
Answered by AI
What other research endeavors have employed Venetoclax in their investigations?
"Presently, 313 trials for Venetoclax are in progress. Out of those studies, 39 have reached the Phase 3 stage. Although Edmonton is home to most clinical trials using this medication, 15752 sites across the world offer it as well."
Answered by AI
What conditions is Venetoclax commonly used to treat?
"Venetoclax is a widely-used medication for treating renal dysfunction. Additionally, it has been used to effectively treat chronic lymphocytic leukemia (CLL), kidney failure, and mantle cell lymphoma (MCL)."
Answered by AI
What is the maximum capacity of participants for this experimental trial?
"Affirmative. Clinicaltrials.gov documents that this clinical trial, which was first made available on August 13th 2019, is actively recruiting participants. The study hopes to recruit 50 patients from a single medical facility."
Answered by AI
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