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Venetoclax + Chemotherapy for Richter's Syndrome

Phase 2

Recruiting

Led By Matthew S. Davids, MD, MMSc

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet hematologic criteria at screening unless significant bone marrow involvement confirmed on biopsy

Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma with biopsy proven transformation to diffuse large B cell lymphoma consistent with Richter's Syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether adding venetoclax to standard chemotherapy (R-EPOCH or R-CHOP) can help treat Richter's Syndrome.

Who is the study for?

Adults diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma that has transformed into diffuse large B cell lymphoma (Richter's Syndrome) can join. They must have certain blood counts, liver and kidney function within set limits, and agree to use contraception. Excluded are those with bleeding disorders, recent cancer treatments, HIV/HBV/HCV infections, significant heart disease, CNS involvement, severe allergies to trial drugs or who are pregnant.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Venetoclax combined with standard chemotherapy regimens R-EPOCH or R-CHOP in treating Richter's Syndrome. Participants will receive Venetoclax alongside a mix of other drugs including Rituximab and various chemotherapeutic agents like Etoposide and Cyclophosphamide.See study design

What are the potential side effects?

Possible side effects include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding tendencies. Liver function may be affected; there could also be allergic reactions to the medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood test results meet the required levels, unless my bone marrow is significantly affected.

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My CLL or SLL has transformed into a more aggressive form known as Richter's Syndrome.

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I am 18 years old or older.

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I can do most of my daily activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Complete Response by 2008 IW-CLL Response Criteria

Secondary outcome measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Overall Survival Rate

Partial Response Rate by 2008 IW-CLL Response Criteria

+1 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

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%

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: VR-EPOCHExperimental Treatment2 Interventions

Standard chemotherapy regimen, DA-EPOCH-R, with a novel oral Bcl-2 inhibitor, venetoclax will be administered to patients Chemotherapy cycles will be administered approximately every 3 weeks Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing

Group II: VR-CHOPExperimental Treatment2 Interventions

Standard chemotherapy regimen, R-CHOP, with a novel oral Bcl-2 inhibitor, venetoclax will be administered to patients Chemotherapy cycles will be administered approximately every 3 weeks Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,914 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,076 Total Patients Enrolled

Matthew S. Davids, MD, MMSc4.69 ReviewsPrincipal Investigator - Dana-Farber Cancer Institute

Dana-Farber Cancer Institute

1 Previous Clinical Trials

72 Total Patients Enrolled

5Patient Review

It's impossible to overstate how important it is to have a doctor you can trust when you've been diagnosed with cancer. Dr. Davids is not only an outstanding oncologist, but he's also a kind and caring individual. He's been a blessing to our family, and we're grateful for everything he's done for us.

Media Library

DA-EPOCH-R Clinical Trial Eligibility Overview. Trial Name: NCT03054896 — Phase 2

Richter Syndrome Research Study Groups: VR-EPOCH, VR-CHOP

Richter Syndrome Clinical Trial 2023: DA-EPOCH-R Highlights & Side Effects. Trial Name: NCT03054896 — Phase 2

DA-EPOCH-R 2023 Treatment Timeline for Medical Study. Trial Name: NCT03054896 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety concerns should be taken into account when prescribing Venetoclax?

"While there is limited evidence of Venetoclax's efficacy, our team assigned it a score 2 due to the available data supporting its safety."

Answered by AI

Have any other trials been conducted that evaluate the efficacy of Venetoclax?

"Presently, Venetoclax is being studied in 219 clinical trials, 28 of which are Phase 3. While a few sites for this drug trial can be found in Boston, Massachusetts, there exist 7198 other locations participating in the study worldwide."

Answered by AI

Are applications currently open for the clinical trial?

"Affirmative. Clinicaltrials.gov displays that this experiment is actively enrolling patients, which was initially posted on March 8th 2017 and recently updated on July 11th 2022. Three sites are seeking 67 participants for the trial."

Answered by AI

What is the cap for enrolment in this clinical experiment?

"To carry out this medical study, 67 patients matching the criteria must be found. Genentech Inc., is managing the clinical trial from various sites such as MD Anderson Cancer Center in Houston and Mayo Clinic located in Rochester."

Answered by AI

Recent research and studies

BloodJournal

Venetoclax Plus Dose-adjusted R-EPOCH for Richter Syndrome

Davids, Matthew S., Kerry A. Rogers, Svitlana Tyekucheva, Zixu Wang, Samantha Pazienza, Sarah K. Renner, Josie Montegaard, et al.. 2022. “Venetoclax Plus Dose-adjusted R-EPOCH for Richter Syndrome”. Blood. American Society of Hematology. doi:10.1182/blood.2021011386.

BloodJournal

Venetoclax Plus Dose-adjusted R-EPOCH for Richter Syndrome

clinicaltrials.govStudy

A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R or R-CHOP for Patients With Richter's Syndrome

Matthew S. Davids, MD 2017. "A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R or R-CHOP for Patients With Richter's Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03054896.