Your session is about to expire
← Back to Search
PI3K Inhibitor
Duvelisib + Venetoclax for Chronic Lymphocytic Leukemia
Phase 1 & 2
Recruiting
Led By Matthew S Davids, MD
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
Age greater to or equal to 18 years
Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma requiring therapy, as per IW-CLL 2008 criteria OR Biopsy proven transformation to diffuse large B cell lymphoma (DLBCL), consistent with Richter's Syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new drug, duvelisib, in combination with an existing FDA-approved drug, venetoclax, as a possible treatment for people with CLL or Richter's Syndrome.
Who is the study for?
Adults diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma needing treatment, or those with Richter's Syndrome after at least one prior therapy (not applicable for Richter's). Must have adequate blood counts, liver and kidney function, agree to use contraception, and be able to consent. Excludes those with central nervous system involvement, recent transplants or active infections, certain virus histories, major surgery within 4 weeks, gastrointestinal disease requiring therapy, pregnancy/breastfeeding individuals.Check my eligibility
What is being tested?
The trial is testing a new drug called duvelisib in combination with an FDA-approved drug venetoclax. It aims to treat participants who have relapsed or are not responding well to previous treatments for CLL/SLL/RS. The study will assess the effectiveness and safety of this drug combo.See study design
What are the potential side effects?
Potential side effects may include diarrhea due to gastrointestinal impact; liver issues reflected by changes in enzyme levels; lowered blood cell counts leading to increased infection risk; fatigue; possible allergic reactions related to medication ingredients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with CLL/SLL needing treatment or have DLBCL due to Richter's Syndrome.
Select...
My kidney function is within the required range.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My kidney function is normal.
Select...
My kidney function is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose of Venetoclax When Administered with Duvelisib
Rate of complete remission
Secondary outcome measures
Cmax
Duration of response
Half-life
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Duvelisib +Venetoclax,Experimental Treatment2 Interventions
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
Duvelisib will be administered orally twice daily
Venetoclax will be administered orally daily
All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duvelisib
2016
Completed Phase 3
~760
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Secura Bio, Inc.Industry Sponsor
8 Previous Clinical Trials
181 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,914 Total Patients Enrolled
Matthew S Davids, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am taking less than 20 mg of corticosteroids daily.My liver is working well.I have a lung condition or severe breathing problems.I have been treated for tuberculosis within the last 2 years.I have not had major surgery in the last 4 weeks.I do not have serious heart problems or recent heart attacks.I haven't had cancer treatment or surgery in the last 2 weeks, except for certain allowed therapies.I can start treatment sooner if my condition worsens, with my doctor's approval.I have a history of HIV, HCV, or HBV.My cancer has spread to my brain or spinal cord.I have been diagnosed with CLL/SLL needing treatment or have DLBCL due to Richter's Syndrome.My kidney function is within the required range.I have been treated with venetoclax or duvelisib before.I have stopped my targeted cancer therapy for enough time before joining.I have a cancer history but only needed hormone therapy.I am on preventive antibiotics with no active infection and not taking banned medications.I have a history of chronic liver disease or veno-occlusive disease.I am not taking any strong medications or eating foods that affect CYP3A enzyme activity.I cannot swallow pills or have a condition that affects my stomach or intestines badly.I have an active gut condition like colitis or IBD that needs treatment.I can take care of myself but might not be able to do heavy physical work.I agree to use effective birth control or abstain from sex during the study.I do not have any ongoing infections needing IV antibiotics.My CLL/SLL has worsened after treatment, but I don't have Richter's Syndrome.I had a stem cell transplant less than 6 months ago or I am being treated for graft vs. host disease.My kidney function is normal.My white blood cell count is high enough, possibly with help from medication.I am taking Coumadin or another blood thinner.My kidney function is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Duvelisib +Venetoclax,
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.
What clinical conditions is Duvelisib typically employed to address?
"Duvelisib is commonly deployed to treat refractory anemias and a variety of lymphomas, such as follicular and small lymphocytic types. It can also help in cases of relapse or resistance for these two cancers."
Answered by AI
Are there still spots available for participants in this research endeavor?
"This clinical trial is actively recruiting, as indicated by the information published on clinicaltrials.gov; first posted on July 12th 2018 and last amended on July 5th 2022."
Answered by AI
Is there a prevalent presence of this trial in North America?
"7 clinical sites are now accepting patient enrollments, including Berkshire Medical Center in Pittsfield and Massachusetts General Hospital in Miami. The University of Miami- Sylvester Comprehensive Cancer Center is also participating along with 4 other medical centres."
Answered by AI
How many participants are contributing to this clinical experiment?
"For this clinical trial to be successful, 67 eligible participants are necessary. Potential candidates can find the appropriate locations for enrollment at either Berkshire Medical Centre in Pittsfield, Florida or Massachusetts General Hospital in Miami, Maine."
Answered by AI
What is the desired outcome of this research endeavor?
"This trial will measure a variety of endpoints, primarily the Rate of complete remission over up to 7 weeks. Secondary points include Half-life, Duration of response according to IW-CLL Criteria and Volume of Distribution."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger