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Venetoclax + Acalabrutinib for Mantle Cell Lymphoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment (acalabrutinib, venetoclax)
- 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.
- 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
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."
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."
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."
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."
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)."
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."
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