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PI3K inhibitor
Idelalisib + Ofatumumab for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Jennifer Brown, MD, PhD
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 ≥ 18 years.
Participants must have CLL / SLL, as documented by a history at some point of an absolute peripheral blood B cell count > 5000, with a monoclonal B cell population co-expressing CD19, CD5, and CD23, or if CD23 negative, then documentation of the absence of t(11;14) or cyclin D1 overexpression. Alternatively patients with lymphadenopathy in the absence of circulating disease will also be eligible for this study if lymph node biopsy establishes the diagnosis of CLL with the above immunophenotype.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs for chronic lymphocytic leukemia and small lymphocytic leukemia.
Who is the study for?
This trial is for adults with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL). Participants must have measurable disease, require treatment based on specific guidelines, and have normal organ/marrow function. Those who've had other recent treatments or malignancies, active infections requiring systemic therapy, significant heart conditions, or are pregnant/lactating cannot join.Check my eligibility
What is being tested?
The study tests a combination of two drugs: Ofatumumab (an antibody against CLL cells) and Idelalisib (a drug blocking cancer cell growth signals), to see if they work better together for treating CLL/SLL than when used separately. The focus is on the side effects of this combo and its impact on the disease.See study design
What are the potential side effects?
Potential side effects include reactions related to immune response due to Ofatumumab, liver enzyme changes from Idelalisib use, fatigue, digestive issues like nausea or diarrhea, and increased risk of infection. Individual experiences may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with CLL/SLL based on specific blood cell counts and markers.
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I have signs of disease that can be measured, like high white blood cell count or large lymph nodes.
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I have CLL and need treatment but haven't received any systemic therapy yet.
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I am mostly self-sufficient and can carry out daily activities.
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My kidney, liver, and bone marrow are functioning within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate of ofatumumab and idelalisib in previously untreated CLL/SLL participants in need of therapy
Secondary outcome measures
CR rate and PFS of ofatumumab and idelalisib.
Cell surface marker phenotype of circulating CLL cells.
Contribution of CT scans to response assessment
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Idelalisib & OfatumumabExperimental Treatment2 Interventions
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
FDA approved
Idelalisib
FDA approved
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,822 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,402 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,791 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have an active liver or bile duct disease.I haven't taken any experimental drugs or joined other clinical studies recently.I do not have any other cancer that could affect the study results.I have a serious heart condition.I do not have any uncontrolled serious health conditions.I am a woman who can have children and I do not use or cannot use birth control.I am a male not using or unable to use birth control.I have CLL and need treatment but haven't received any systemic therapy yet.I haven't had any treatment for CLL or any other cancer treatment in the last 4 to 6 weeks.I have had a serious stroke or brain event in the last 6 months.I am on 20mg or less of prednisone daily and have been on this dose for at least two weeks.I have been diagnosed with CLL/SLL based on specific blood cell counts and markers.I have signs of disease that can be measured, like high white blood cell count or large lymph nodes.I am mostly self-sufficient and can carry out daily activities.My kidney, liver, and bone marrow are functioning within normal limits.I am not on long-term antibiotics or antivirals for an infection.
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Idelalisib & Ofatumumab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Idelalisib been sanctioned by the FDA?
"The safety of Idelalisib was classified as a 2 on the 1 to 3 scale due to its position in Phase 2 trials, which have produced evidence that it is safe but not yet proven effective."
Answered by AI
Have there been any previous investigations related to Idelalisib?
"At the present time, there are 34 studies on Idelalisib in progress. Of those trials, 8 have reached Phase 3 status. Although most of these research projects take place in Hualien, Texas; 1217 trial sites across the world are running tests with this medication."
Answered by AI
To what extent is participation seen in this research project?
"No longer accepting volunteers, this trial was initiated on June 1st 2014 and the latest update took place on September 19th 2022. For those still seeking to participate in clinical studies, there are 1522 trials recruiting participants with leukemia or lymphoid diseases as well as 34 enrolling individuals who might benefit from Idelalisib treatment."
Answered by AI
Is enrollment for this trial still available?
"As indicated on clinicaltrials.gov, this experiment is no longer recruiting patients as of September 19th 2022. Initially posted on June 1st 2014, the study has since concluded its search for participants. Fortunately, there are a total of 1556 other studies presently enrolling candidates across the globe."
Answered by AI
Is this the inaugural clinical trial of its kind?
"Currently, Idelalisib is being tested in 34 active trials across 418 cities and 52 nations. In 2010 GlaxoSmithKline sponsored the first study involving 32 patients which successfully concluded its Phase 2 process. After that initial trial, 90 additional investigations have been undertaken to confirm safety and effectiveness of this drug."
Answered by AI
In what clinical scenarios is Idelalisib the most prevalent treatment option?
"Idelalisib is usually prescribed to treat multiple sclerosis. It has also been found successful in managing refractory fludarabine, alemtuzumab resistance and post-treatment regimens."
Answered by AI
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