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AVO for Mantle Cell Lymphoma
Study Summary
This trial is testing whether or not the combination of these three drugs can help to treat mantle cell lymphoma, which is a type of cancer that affects the lymph nodes.
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.Side effects data
From 2020 Phase 2 trial • 177 Patients • NCT04346199Trial Design
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Who is running the clinical trial?
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- I haven't had major surgery or significant injury in the last 4 weeks and don't need any during the study.My lymphoma has been confirmed as mantle cell type by a lab test.I need medication for stomach acid.My organs and bone marrow are working well.I agree to use birth control or abstain from sex for safety after my treatment.I am currently on or recently needed IV antibiotics for an infection.I have had at least one treatment for my lymphoma that included an anti-CD20 drug (part A) or; I have only been treated with steroids or radiotherapy for my lymphoma (parts B and C).I cannot swallow pills well or have serious digestive issues.I am 18 years old or older.I have lymphoma with a TP53 mutation or high TP53 and can't have a stem cell transplant.I am eligible for a stem cell transplant and my lymphoma does not show TP53 mutations or high TP53 expression.I was diagnosed with a bleeding stomach ulcer by a camera test within the last 3 months.My cancer has spread to my brain or its coverings.I have HIV or active hepatitis B or C.I have a bleeding disorder or hemophilia.I have had cancer before, but it fits the exceptions.I can provide a tissue sample and blood for ClonoSEQ®ID marker identification.I haven't had lymphoma treatment, am eligible for a stem cell transplant, and don't have TP53 mutations.I have a tissue sample and blood test results from my initial diagnosis for molecular marker testing.My blood test for specific cancer markers was inconclusive.I can care for myself but may not be able to do active work.I need treatment for my condition because it's causing symptoms or affecting my organs.I have a tumor or lymph node that is at least 1.5 cm big, or my cancer affects my bone marrow or spleen.I may have had a stem cell transplant or CAR T-cell therapy.I am currently on medication that suppresses my immune system.I have not received any live vaccines in the last 28 days and do not need any during the study.I need treatment with strong medication that affects liver enzymes.You are not currently taking or have not taken any experimental drugs within the past 4 weeks.I have a serious heart condition that is currently affecting me.I have had fever, night sweats, or lost more than 10% of my weight in the last 6 months.My blood counts are low due to my illness affecting my organs.I have lymphoma, can't have a stem cell transplant, and either have a TP53 mutation or high TP53 expression.I will not become pregnant or will use effective birth control during and after treatment.You are currently pregnant or breastfeeding.I have not had a stroke or brain bleed in the last 6 months.I have had at least one treatment that included anti-CD20 for my cancer, or I've only had steroids or radiotherapy.I need warfarin or similar drugs for blood thinning.My condition worsened after treatment with a BTK or BCL2 inhibitor.I need treatment with specific drugs that affect how my body processes medications.I have symptoms due to enlarged lymph nodes or spleen.I have symptoms caused by cancer outside the lymph nodes.I have had previous treatments, including stem cell transplant or CAR T-cell therapy, for my relapsed or refractory condition.
- Group 1: Acalabrutinib, Venetoclax, and Obinutuzumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- 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
Could you describe any other investigations into Acalabrutinib's efficacy?
"Presently, there are 339 active clinical trials for acalabrutinib with 43 of them being in their final phase. Most studies are located within the city limits of Edmonton, Alberta; however, 11 locations worldwide have initiated Acalabrutinib research projects."
What are the chief goals of this study?
"The primary aim of this 7-month trial is to determine the Complete Remission Rate. Secondary metrics include an examination of overall survival, and a rate of peripheral blood MRD-negativity after seven cycles as measured by clonoSEQ® assay (which uses Next Generation Sequencing). Furthermore, CR will be evaluated radiographically using 2014 Lugano criteria and bone marrow biopsy via histology, immunohistochemistry, and flow cytometry if relevant."
What is the quota for individuals participating in this experiment?
"Affirmative. Clinicaltrials.gov shows that this medical study is seeking participants, with the original posting being on July 2nd 2021 and a recent update made on August 8th 2022. Up to 53 individuals can be recruited across two trial sites."
Are there any open positions in this research endeavor?
"Affirmative, the clinical trial registry shows that this study is currently enrolling participants. It was originally made available on July 2nd 2021 and underwent its last update on August 8th 2022. The goal is to enlist 53 patients at two different medical centres."
To what ailment is Acalabrutinib typically prescribed?
"Acalabrutinib has been approved to manage small lymphocytic lymphoma, leukemia, and mantle cell lymphoma that is unresponsive to prior therapy."
Is this experiment a groundbreaking endeavor?
"Acalabrutinib has been under investigation since 2014, when a Phase 1 & 2 trial was sponsored by Acerta Pharma BV. This medical intervention is now in 339 active studies located across 1407 cities and 55 nations."
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