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Kinase Inhibitor
Acalabrutinib + Venetoclax + Rituximab for Mantle Cell Lymphoma (TrAVeRse Trial)
Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 67 months
Awards & highlights
TrAVeRse Trial Summary
This trial studies a new cancer treatment for MCL patients who haven't been treated before to see if it helps reduce any remaining cancer cells.
Who is the study for?
This trial is for adults with newly diagnosed Mantle Cell Lymphoma (MCL) who need treatment and have not received any prior therapies for MCL. They should be in clinical Stage II, III, or IV, able to consent, and have at least one measurable site of disease. Participants must agree to use effective contraception and cannot join if they are pregnant or breastfeeding, have severe illnesses that could affect the study's safety or outcomes, active infections like HIV/Hepatitis B/C, other active cancers (with some exceptions), significant heart issues, or known allergies to the drugs being tested.Check my eligibility
What is being tested?
The TrAVeRse study tests a combination of Acalabrutinib plus Venetoclax and Rituximab (AVR) in treatment-naïve MCL patients. It aims to see how many achieve MRD-negative complete remission after 13 cycles of AVR. Those who do will either continue with Acalabrutinib or enter observation. If participants progress during observation, they may receive Acalabrutinib again.See study design
What are the potential side effects?
Possible side effects include diarrhea; headache; fever; fatigue; muscle pain; bruising; nausea; constipation; vomiting; rash as well as more serious ones such as bleeding problems, high blood pressure, irregular heartbeat among others.
TrAVeRse Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 67 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 67 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Complete Response (CR) rate
Duration of Response (DoR)
Event Free Survival (EFS)
+7 moreTrAVeRse Trial Design
1Treatment groups
Experimental Treatment
Group I: Acalabrutinib + Venetoclax + RituximabExperimental Treatment3 Interventions
Acalabrutinib + Venetoclax + Rituximab (AVR)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050
Venetoclax
2019
Completed Phase 3
~1990
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,575 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have uncontrolled autoimmune blood disorders.My condition is at a moderate to advanced stage and needs treatment.My lymphoma has spread to my brain or spinal cord.I have been diagnosed with or currently have progressive multifocal leukoencephalopathy.I am not currently bleeding from a stomach ulcer.My tumor samples are available for detailed genetic testing.My treatment goal is to reduce my tumor size before stem cell transplant.I do not have any severe illnesses that could affect my safety or the study's results.I have not had a stroke or brain bleed in the last 6 months.I have received treatments for mantle cell lymphoma.I haven't had a live vaccine in the last 28 days.My cancer is confirmed as mantle cell lymphoma with specific genetic features.I can care for myself, but my daily activities might be limited.I have not had major surgery in the last 4 weeks.I do not have serious heart problems or recent heart attacks.I am at least 18 years old or the legal age of consent where the study is conducted.My organs and bone marrow are working well.I am currently on medication to suppress my immune system.I am currently using or have recently used strong medication that affects liver enzymes.I do not have any active infections that could make participating in the study unsafe.I need to keep taking warfarin or similar blood thinners.I have a cancerous area that can be measured and is larger than 1.5 cm in one direction or more than 1.0 cm in another, as confirmed by CT or MRI.I am HIV positive.I have a condition that affects how my body absorbs food.My cancer mainly affects my spleen, bone marrow, or blood.I have a known G6PD deficiency.I have no active cancer needing treatment, except for certain skin cancers or cancers in remission for 2+ years.I have signed a consent form for optional genetic research.
Research Study Groups:
This trial has the following groups:- Group 1: Acalabrutinib + Venetoclax + Rituximab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locations are carrying out the experiment in this urban area?
"At the moment, this experiment is enrolling patients from 11 different medical centres. These locations are dispersed across New york, Cleveland and Philadelphia as well as 8 other cities. To reduce travel requirements, we recommend selecting a site closest to you for participation."
Answered by AI
Are any new participants being accepted into this experiment at the moment?
"According to clinicaltrials.gov, this medical study is not presently accepting patients for review. Initially posted on August 30th 2023, and last updated on July 17th 2023; although it's inactive at the moment, 1,713 other studies are recruiting participants."
Answered by AI
Has the FDA sanctioned Acalabrutinib + Venetoclax + Rituximab as a viable treatment?
"Our evaluation of the safety profile associated with Acalabrutinib, Venetoclax, and Rituximab is a 2 due to limited clinical evidence regarding efficacy but some data supporting safe usage."
Answered by AI
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