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Autologous Immune Cell Therapy for Leukemia
Study Summary
This trial is testing a new cancer treatment composed of patients' own immune cells. The treatment is for patients with CLL/SLL, a type of blood cancer, who have relapsed or are relapsing during treatment with ibrutinib or acalabrutinib.
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?
Media Library
- I have tried at least one treatment after ibrutinib or acalabrutinib and my condition worsened.I am currently receiving IV treatment for a long-term infection.My cancer is getting worse despite taking ibrutinib or acalabrutinib.I have CLL or SLL that can be seen on scans.My CLL/SLL is getting worse despite treatment with ibrutinib or acalabrutinib, and I have specific genetic changes.I have had an organ transplant or cell therapy in the last 20 years.My bone marrow functions well enough for treatment.I am currently on my first treatment with ibrutinib or acalabrutinib for my condition.I have tried at least one treatment after ibrutinib or acalabrutinib and my condition worsened.I haven't had chemotherapy, immunotherapy, or similar treatments in the last 30 days or 5 half-lives, except for ibrutinib or acalabrutinib.I have not received a live vaccine in the last 28 days.I take more than 5 mg/day of steroids for a chronic condition.I do not have active infections, blood disorders, or major illnesses affecting my heart, lungs, or immune system.My cancer has spread to my brain or spinal cord.I can care for myself and doctors expect me to live at least 3 more months.My heart pumps blood effectively, with an ejection fraction over 45%.I am currently on my first treatment with either ibrutinib or acalabrutinib.My cancer is getting worse despite taking ibrutinib or acalabrutinib.My heart pumps well, with an ejection fraction over 45%.My bone marrow functions well enough for treatment.I need treatment with a blood thinner like warfarin.My CLL/SLL is getting worse despite taking ibrutinib or acalabrutinib, and I don't have del 17p or TP53 mutations.I've had at least one treatment for my condition and am now on ibrutinib or acalabrutinib without specific genetic mutations.My condition has changed into a more aggressive form.I have CLL or SLL that can be seen on scans.My CLL/SLL is getting worse despite taking ibrutinib or acalabrutinib, and I don't have del 17p or TP53 mutations.I've had at least one treatment for my condition and am now on ibrutinib or acalabrutinib.I can care for myself and doctors expect me to live at least 3 more months.My CLL/SLL is worsening despite treatment with ibrutinib or acalabrutinib, and I have del 17p or TP53 mutation.
- Group 1: Cohort 2
- Group 2: Cohort 1b
- Group 3: Cohort 1a
- Group 4: Cohort 3
- 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
Does this research mark a pioneering approach to the topic?
"Scientific research into IOV-2001 began in 2006, with the initial trial sponsored by Key Biologics, LLC. Following its successful completion involving 1230 participants, this pharmaceutical received Phase 2 drug approval. At present there are 24 concurrent trials taking place in 45 cities and 10 countries worldwide."
Are there any precedents of IOV-2001 being trialled in past studies?
"Currently, 24 studies exploring IOV-2001 are in progress and none of them have reached Phase 3. A majority of the trials for this drug occur in Meldola, FC; but there also exist 70 other locations involved with research about it."
What is the current scope of this clinical experiment?
"At present, there are 5 active research sites for this clinical trial. These include the Baptist Cancer Center in Memphis, Allegheny Health in Pittsburgh and Moffitt Cancer Centre in Tampa as well as an additional 5 locations."
Is this research endeavor open to participation by octogenarians?
"This clinical trial has a fairly wide age range for participants with 18 being the minimum and 70 being the maximum."
How many participants can partake in this clinical trial?
"The sponsor, Iovance Biotherapeutics Inc., has determined that 70 qualified participants are necessary for the success of this trial. The clinical centres participating include Baptist Cancer Center in Memphis, Tennessee and Allegheny Health in Pittsburgh, Pennsylvania."
Is the research center still open to new participants?
"According to the clinicaltrials.gov record, this trial is actively recruiting participants after first posting on February 19th 2020 and last being modified on January 31st 2022."
Am I a suitable candidate for this clinical trial?
"This medical trial will accept a cohort of 70 lymphoma patients, aged 18 to 70. To be considered eligible for the study, individuals must have documented resistance or progression in regards to ibrutinib or acalabrutinib (as specified by BTK resistant mutation), an ECOG performance status of 0-1 and estimated life expectancy greater than 3 months; Cohort 2 requires only one prior regimen with either ibrutinib or acalabrutinib while Cohort 3 necessitates at least 1 extra line of therapy beyond those two as well as adequate bone marrow function that can withstand NMA-"
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