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Obinutuzumab + Venetoclax vs. Chlorambucil for Chronic Lymphocytic Leukemia
Study Summary
This trial is testing a new combination of drugs for people with CLL and other medical conditions. The trial will last about a year, with follow-up for up to 9 years.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 229 Patients • NCT02264574Trial Design
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- I am not infected with HIV or HTLV-1.I haven't had a serious infection needing treatment in the last 2 months.I have chronic lymphocytic leukemia that has not been treated before.I have an uncontrolled immune system disorder affecting my red blood cells or platelets.I had cancer before but have recovered from the treatment side effects.My blood cell counts are good without needing extra help, unless it's because of my CLL.I need to take blood thinners like warfarin.I haven't used any experimental drugs or cancer treatments in the last 4 weeks.My CLL condition requires treatment.I haven't taken strong or moderate CYP3A inhibitors or inducers in the last week.I am currently pregnant or breastfeeding.My CLL has transformed into a more aggressive form of lymphoma.My health issues won't stop me from getting the trial's treatment, except for problems with my eyes, ears, nose, or throat.My cancer has spread to my brain or spinal cord.I have been diagnosed with progressive multifocal leukoencephalopathy.My liver is working well.My kidneys are not working well.
- Group 1: Obinutuzumab + Chlorambucil
- Group 2: Safety Run-in Obinutuzumab + Venetoclax
- Group 3: Obinutuzumab + Venetoclax
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has Obinutuzumab been investigated in other research?
"There are currently 295 Obinutuzumab trials underway, with 39 in Phase 3. While Edmonton, Alberta has a high density of Obinutuzumab clinical trials, there are 8856 total locations for these trials."
Could you please outline the potential dangers of Obinutuzumab?
"Obinutuzumab has received a score of 3 for safety. This is because it is a Phase 3 trial, and thus there is some data demonstrating its efficacy as well as multiple rounds of data affirming its safety."
Obinutuzumab is most commonly used to treat what condition?
"While obinutuzumab is most commonly used as a lymphoma treatment, it can also be taken to help manage other conditions like mantle cell lymphoma (mcl), small lymphocytic lymphoma, and indolent lymphoma."
Is it possible to sign up for the clinical trial at this time?
"This particular clinical trial, as noted on clinicaltrials.gov, is not recruiting patients at the moment. The study was first posted on December 31st, 2014 but was last updated on September 28th, 2022. Although this study is not looking for candidates, there are 1864 other trials that are."
How many people have been asked to participate in this trial thus far?
"Unfortunately, this clinical trial is not presently enrolling patients. The study was posted December 31st, 2014 and was last updated September 28th, 2022. However, there are 1569 other trials for leukemia and 295 trials for Obinutuzumab enrolling patients right now."
What is unique about this clinical trial in comparison to others?
"As of now, there are 295 active Obinutuzumab clinical trials in 1362 cities and 52 countries. The very first one was completed in 2012 by Janssen Research & Development, LLC. That initial trial had 232 patients and finished Phase 3 drug approval. In the 8 years since then, there have been 113 more trials."
How many locations are conducting this experiment?
"To limit the amount of travelling required from potential participants, this trial is currently recruiting patients from 12 sites that are located in cities such as Atlanta, Harvey and Detroit."
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What state do they live in?
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What portion of applicants met pre-screening criteria?
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