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JCAR017 for Chronic Leukemia or Lymphoma
Study Summary
This trial is testing a new drug, JCAR017, to see if it is safe and effective at treating leukemia in adults. The trial will be conducted in two parts, with a separate cohort testing the drug in combination with ibrutinib or venetoclax. All subjects will be monitored for safety and efficacy, and the pharmacokinetics of JCAR017 will be studied.
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.Trial Design
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Who is running the clinical trial?
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- I am eligible for a therapy combining ibrutinib and JCAR017.My condition has progressed to Richter's transformation.I am experiencing severe symptoms from a transplant rejection.I have a significant brain or nervous system condition.My cancer is CD19 positive, even after CD19-targeted treatment.My cancer has spread into blood vessels.I have unmanaged blood clots in my veins.I am not taking any strong medication that affects liver enzymes with my current cancer treatment.I have been diagnosed with CLL and need treatment according to my doctor.I have SLL with specific symptoms and a certain level of B lymphocytes.I have tried and not responded to BTK inhibitor treatment or was deemed ineligible for it.I have had another type of cancer in the last 2 years.My kidneys, liver, lungs, and heart are functioning well.I am eligible for specific drug combination treatments.My cancer has spread to my brain or spinal cord.I have received gene therapy before.I have had heart problems in the last 6 months.I do not have active hepatitis B, C, or HIV.My bone marrow is healthy enough for strong chemotherapy.I haven't taken certain medications before my leukapheresis.I am fully active and can carry on all my pre-disease activities without restriction.I have received previous treatment, but not in the ibrutinib + JCAR017 combination.I am suitable for or already have a central or peripheral line for blood filtering procedures.I do not have any untreated infections.
- Group 1: Phase 1 JCAR017 + ibrutinib
- Group 2: Phase 1 JCAR017 + venetoclax
- Group 3: Phase 2 JCAR017 monotherapy
- Group 4: Phase 1 JCAR017 monotherapy
- 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
How many participants are receiving care in this investigation?
"Unfortunately, recruitment for this research has closed. The clinical trial was initially listed on the 27th November 2017 and updated lastly on 18 October 2022. However, if you are still looking to partake in a medical study there are currently 2861 studies admitting patients with leukemia-related afflictions and 349 trials involving JCAR017 (lisocabtagene maraleucel) + ibrutinib actively recruiting participants."
What is the ultimate goal of this research endeavor?
"As reported by Juno Therapeutics, which is a subsidiary of Celgene Corporation, the primary objective measured over 48 months will be Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities. Other secondary endpoints include Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR), Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: lab abnormalities, and Phase1JCAR017andvenetoclaxcombinationdoseexpansiontherapyarm:MRD-negativeresponserateinperipheralblood."
Are there any open slots still available to join this research initiative?
"This clinical trial has already concluded its recruitment process, with posts being made on the November 27th 2017 and last updates from October 18th 2022. For those seeking to participate in other studies, there are presently 2861 trials actively looking for patients suffering from leukemia or lymphocytic chronic B-cell conditions, as well as 349 investigations concerning JCAR017 (lisocabtagene maraleucel) + ibrutinib searching for participants."
How many healthcare facilities are participating in this research endeavor?
"This clinical trial has 42 operating centres, including Local Institution - 0062 in Detroit, Local Institution - 0077 in New Brunswick, and Local Institution - 0010in San Francisco. The other 39 sites are situated across the nation."
Could you provide an overview of the research conducted on the combination therapy of JCAR017 (lisocabtagene maraleucel) with ibrutinib?
"As of now, there are 349 separate studies looking into the potential therapeutic benefits of JCAR017 (lisocabtagene maraleucel) + ibrutinib. 45 trials have already reached Phase 3 and with 11939 research centres located across Edmonton, Alberta alone, these investigations will likely continue for a while longer."
What applications is the JCAR017 (lisocabtagene maraleucel) + ibrutinib combination commonly employed for?
"The combination of JCAR017 (lisocabtagene maraleucel) and ibrutinib may be used to address mantle cell lymphoma, refractory diffuse large b-cell lymphoma, and other diseases for which patients have had two or more lines of systemic therapy."
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