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Alkylating agents
Venetoclax + Polatuzumab Vedotin + R-CHP for Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least one bi-dimensionally fluorodeoxyglucose-avid measurable lymphoma lesion on PET/CT scan, defined as > 1.5 cm in its longest dimension on CT scan
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug, and is looking at how safe and effective it is, as well as how it is metabolized by the body.
Who is the study for?
This trial is for adults with untreated BCL-2 positive Diffuse Large B-Cell Lymphoma (DLBCL). Participants must be in good physical condition (ECOG 0, 1, or 2), have a life expectancy over 6 months, and agree to use contraception. Exclusions include prior organ transplants, recent major surgery, active infections or substance abuse issues, certain viral infections like HIV/HBV/HTLV-1, pregnancy/breastfeeding intentions within specific timeframes post-treatment.Check my eligibility
What is being tested?
The study tests the combination of Venetoclax with Polatuzumab Vedotin plus Rituximab and CHP chemotherapy in people who haven't been treated for DLBCL before. It's an early-phase trial aiming to understand safety and how the body processes these drugs across different groups of about ten participants each.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Heart function might be affected due to one of the drugs tested. There could also be allergic reactions related to drug infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a lymphoma lesion larger than 1.5 cm that shows up on PET/CT scans.
Select...
I agree to not have sex or will use a condom, and I won't donate sperm.
Select...
My blood counts are within a healthy range.
Select...
I have CD20-positive DLBCL and have not received any treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer cells show high levels of BCL-2 protein.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Complete Response (CR) rate at the end of treatment
Duration of Response (DOR)
Objective Response Rate (ORR) at the end of treatment
+4 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Pneumonia pseudomonal
11%
Hypokalaemia
11%
Dermatitis
11%
Rhinovirus infection
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
Trial Design
2Treatment groups
Experimental Treatment
Group I: Venetoclax (Schedule B)Experimental Treatment6 Interventions
Participants enrolled in dosing Schedule B will receive a total of six 21-day cycles of venetoclax treatment for 10 days in combination with Polatuzumab Vedotin + R-CHP as described below:
Schedule B: Participants will self-administer Venetoclax orally (PO) once daily (QD) at a dose of 800 mg for 10 consecutive days as follows:
Cycle 1: 10 consecutive days of dosing on Days 4-10. Cycles 2-6: 10 consecutive days of dosing on Days 1-10.
Group II: Venetoclax (Schedule A)Experimental Treatment6 Interventions
Participants enrolled in dosing Schedule A will receive a total of six 21-day cycles of venetoclax treatment for 5 days in combination with Polatuzumab Vedotin + R-CHP (Rituximab, Cyclophosphamide, Doxorubicin and Prednisone) as described below:
Schedule A: Participants will self-administer Venetoclax orally (PO) once daily (QD) at a dose of 800 mg for 5 consecutive days as follows:
Cycle 1: 5 consecutive days of dosing on Days 4-8. Cycles 2-6: 5 consecutive days of dosing on Days 1-5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Doxorubicin
2012
Completed Phase 3
~7940
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Venetoclax
2019
Completed Phase 3
~1990
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3780
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,089,004 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,452 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lymphoma lesion larger than 1.5 cm that shows up on PET/CT scans.You have a certain score on the International Prognostic Index (IPI) scale, which helps predict the outcome of your condition.I have had an organ transplant.You are expected to live for at least 6 more months.I agree to not have sex or will use a condom, and I won't donate sperm.My blood counts are within a healthy range.I do not have conditions that affect how my body absorbs food.I don't have any serious health issues that would stop me from safely completing the study.I have not had a blood transfusion in the last 14 days.I have CD20-positive DLBCL and have not received any treatment.I can provide samples of my tumor before joining the study.I have been diagnosed with a type of B-cell lymphoma that doesn't fit into usual categories.I can take care of myself and am up and about more than half of my waking hours.I have not received any live vaccines in the last 28 days.I have not had any infections that could affect my safety in the last week.I have not had any other cancers in the last 2 years.My cancer cells show high levels of BCL-2 protein.I haven't used any monoclonal antibody or investigational therapy recently.I have tested positive for Hepatitis B/C or HTLV-1.I have not had major surgery in the last 6 weeks, except for diagnostic purposes.I have had treatment for DLBCL or HGBCL, but only short-term steroids for symptom relief.I am HIV positive.I have had a brain infection called progressive multifocal leukoencephalopathy.You have used illegal drugs or been dependent on alcohol within the past year.I am not pregnant, breastfeeding, nor planning to become pregnant soon after the treatment ends.I might have tuberculosis.I have mild to severe nerve damage in my hands or feet.I have a significant history of liver disease.I have received treatment for a slow-growing type of lymphoma.I haven't needed strong antibiotics for a serious infection in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax (Schedule B)
- Group 2: Venetoclax (Schedule A)
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.
Has Venetoclax been investigated in other scientific investigations?
"Venetoclax first emerged as a research topic in 1993, when the National Institutes of Health Clinical Center on Rockville Pike began studying it. Since then, 2418 studies have completed and there are currently 1600 open clinical trials happening around Nashville, Tennessee."
Answered by AI
To what extent is the study population participating in this research?
"Affirmative, the information hosted on clinicaltrials.gov indicates that this medical study is currently seeking volunteers. The trial was initially presented on July 2nd 2021 and has been revised most recently on November 10th 2022. Approximately 50 patients are required to be enrolled from 3 distinct sites."
Answered by AI
Has the U.S. Food and Drug Administration sanctioned Venetoclax?
"The safety of Venetoclax has been rated as a 1 on our scale due to the Phase 1 status of this trial, which indicates there is limited data backing its efficacy and security."
Answered by AI
For which conditions is Venetoclax commonly prescribed?
"Venetoclax is the primary drug of choice for treating various types of lung cancer, as well as thyroiditis, polyangium, and neuroblastoma (nb)."
Answered by AI
Are any patients being admitted to the experiment at this juncture?
"Affirmative, the information stored on clinicaltrials.gov implies that recruitment for this medical trial is ongoing; it was initially posted in July 2021 and most recently updated November 10th 2022. The study seeks to recruit 50 patients from 3 distinct locations."
Answered by AI
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