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Alkylating agents
Bendamustine + Rituximab + Venetoclax for Mantle Cell Lymphoma (PrE0405 Trial)
Phase 2
Waitlist Available
Research Sponsored by PrECOG, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 60 years.
Patients must not have conditions that preclude oral administration or absorption of medications through the GI tract, including but not limited to the inability to swallow pills or malabsorption syndromes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall survival (os) was assessed from the start to completion of induction treatment (6 months) through the completion of maintenance treatment (24 months) for up to 60 months of per-protocol study follow-up.
Awards & highlights
PrE0405 Trial Summary
This trial will test the effectiveness of combining venetoclax with bendamustine and rituximab to treat mantle cell lymphoma.
Who is the study for?
This trial is for people over 60 with untreated Mantle Cell Lymphoma. They must have measurable disease, no recent other cancers (with some exceptions), and not be on certain medications like warfarin or strong CYP3A inhibitors. Participants need functioning major organs, no active hepatitis B/C or HIV, and can't be pregnant or breastfeeding. They should agree to use two forms of contraception if applicable.Check my eligibility
What is being tested?
The study tests a combination of venetoclax (a pill that targets proteins aiding cancer growth), bendamustine, and rituximab as initial treatment for Mantle Cell Lymphoma. After six cycles, maintenance therapy with rituximab may follow based on the doctor's judgment.See study design
What are the potential side effects?
Possible side effects include low blood cell counts leading to increased infection risk, fatigue, nausea, diarrhea, liver function changes, allergic reactions to medication components and potential bleeding complications.
PrE0405 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
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I can take pills and my body can absorb medication properly.
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My cervical cancer is in its early stages and has not spread.
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I can take care of myself and am up and about more than half of the day.
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My lymphoma is confirmed to be mantle cell type with specific genetic markers.
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I do not have lymphoma in my brain or spinal cord.
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I have not had chemotherapy, radiotherapy, or immunotherapy for lymphoma.
Select...
My kidneys work well enough, with a creatinine clearance of 40 mL/min or more.
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I do not plan to have a stem cell transplant in my first remission.
Select...
My skin melanoma was caught early and treated.
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I have a lymph node larger than 1.5 cm or an enlarged spleen over 15 cm.
Select...
I have not had a transplant of stem cells or any organ except for the cornea.
Select...
I am a woman who can have children and have had a recent pregnancy test.
Select...
I do not have any ongoing, untreated infections.
Select...
I haven't had any cancer except for certain types in the last year.
PrE0405 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ overall survival (os) was assessed from the start to completion of induction treatment (6 months) through the completion of maintenance treatment (24 months) for up to 60 months of per-protocol study follow-up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overall survival (os) was assessed from the start to completion of induction treatment (6 months) through the completion of maintenance treatment (24 months) for up to 60 months of per-protocol study follow-up.
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) Rate at End of Induction
Secondary outcome measures
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Overall Response
Overall Survival (OS)
+1 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
PrE0405 Trial Design
1Treatment groups
Experimental Treatment
Group I: InductionExperimental Treatment3 Interventions
Venetoclax, bendamustine and rituximab as induction therapy for 6 cycles of 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Bendamustine
2015
Completed Phase 3
~2950
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,656 Total Patients Enrolled
PrECOG, LLC.Lead Sponsor
17 Previous Clinical Trials
7,425 Total Patients Enrolled
Craig Portell, MDStudy ChairUniversity of Virginia
1 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken certain medications within the last week.I am 60 years old or older.I have not eaten grapefruit, Seville oranges, or star fruit in the last 3 days.I do not have active hepatitis B nor am I a chronic carrier.I can take pills and my body can absorb medication properly.My cervical cancer is in its early stages and has not spread.I can take care of myself and am up and about more than half of the day.My lymphoma is confirmed to be mantle cell type with specific genetic markers.I do not have lymphoma in my brain or spinal cord.I do not have active hepatitis C or my hepatitis C is treated and undetectable.I do not have any severe illnesses or mental health conditions that could interfere with the study.I do not use warfarin but may be on other blood thinners.I am not taking strong or moderate drugs that affect liver enzymes.I have not had chemotherapy, radiotherapy, or immunotherapy for lymphoma.My kidneys work well enough, with a creatinine clearance of 40 mL/min or more.You cannot have allergies to both xanthine oxidase inhibitors and rasburicase.I am not taking any strong or moderate drugs that speed up drug breakdown.I am not pregnant or breastfeeding and agree to use two forms of birth control if applicable.My organs are functioning well, as tested within the last 2 weeks.I do not plan to have a stem cell transplant in my first remission.My skin melanoma was caught early and treated.I have a lymph node larger than 1.5 cm or an enlarged spleen over 15 cm.I am not taking strong or moderate P-gp inhibitors.I have not had a transplant of stem cells or any organ except for the cornea.I am a woman who can have children and have had a recent pregnancy test.I do not have any ongoing, untreated infections.My bilirubin levels are within the normal range, or slightly higher if I have Gilbert's syndrome.I have had successful treatment for a non-melanoma skin cancer.I haven't had any cancer except for certain types in the last year.I do not have active HIV.My prostate cancer is low grade and has been stable for 6 months without treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Induction
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.
Are investigators still looking for participants in this experiment?
"Data from clinicaltrials.gov suggests that this trial is not presently recruiting patients, though it was active at some point between January 13th 2020 and May 11th 2022. There are 2414 other trials currently enrolling patients if you're seeking medical participation opportunities."
Answered by AI
At how many different facilities is this research being conducted?
"So far, this study has recruited 10 patients from locations including the Reading Hospital/McGlinn Cancer Institute in West Reading, Mayo Clinic in Rochester, and Penn State Cancer Institute in Hershey."
Answered by AI
What is the latest word on Venetoclax's FDA status?
"While there is some evidence suggesting that Venetoclax is safe, it only received a 2 because Phase 2 trials have not yielded data in support of efficacy."
Answered by AI
What other scientific research has been conducted on Venetoclax?
"As of now, there are 652 ongoing clinical trials for Venetoclax with 120 of them being Phase 3. The majority of these trials are taking place in Edmonton, however, there are 21267 locations total running clinical trials for Venetoclax."
Answered by AI
What are some common illnesses that Venetoclax helps cure?
"Venetoclax is most commonly used for treatment of diffuse large b-cell lymphoma (dlbcl). It can also be administered to treat multiple other conditions such as hodgkin disease, b-cell lymphomas, and polyangium."
Answered by AI
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