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CAR-T Cell Therapy for Lymphoma and Leukemia
Study Summary
This trial is testing the effects of CAR-T cells on patients with B-cell lymphoma or chronic lymphocytic leukemia that has come back or stopped responding to treatment.
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 may need or have recently taken steroids or drugs that weaken my immune system.My cervical cancer was treated and shows no signs of being present.My cancer was treated to be cured and currently shows no active signs.My brain metastases are under control, and I have no neurological symptoms.My bladder cancer has been treated and is not invasive.My cancer did not respond to initial treatment or has come back after 3+ treatments.I am mentally capable of understanding and following the study's requirements.I have had cancer in the last 3 years, but it might be an exception.I had non-melanoma skin cancer, but it's now treated and shows no signs of disease.My lymphoma did not respond to initial treatment or has returned after two treatments.I haven't had cancer treatment, including immunotherapy, in the last 14 days and haven't received anti-CD19 CAR T-cells.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use effective birth control.My condition is expected to have over a 95% chance of not returning after treatment.My lymphoma or leukemia does not respond to standard treatments.My kidney function is normal, with creatinine below 2 mg/dL.My lymphoma tumor is at least 1.5 cm^3 in size.My cancer cells are mostly positive for CD19 or CD20.My lung function test shows I have reduced breathing capacity.You have had a bad reaction or allergy to any of the drugs used in this study, specifically cyclophosphamide or fludarabine.My hemoglobin level is at least 8 g/dL.My prostate cancer has a low Gleason score and my PSA levels have been undetectable for over a year.My major organs and bone marrow are healthy enough for a T cell transplant.My breast cancer has been treated and currently shows no signs of the disease.I am willing to undergo a procedure to collect white blood cells.
- Group 1: Treatment (fludarabine, cyclophosphamide, CD19/CD20 T-cells)
- 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
Are there any openings remaining for this experimental procedure?
"The details posted on clinicaltrials.gov demonstrate that this medical trial is still recruiting participants, having been initially publicized in October of 2019 and most recently updated on September 9th 2022."
What conditions usually warrant the utilization of Cyclophosphamide?
"Cyclophosphamide is commonly prescribed to treat systemic juvenile idiopathic arthritis (sjia). Additionally, it has been seen as a potential therapeutic option for multiple sclerosis, leukemia, myelocytic acute and retinoblastoma patients."
How many individuals have been enrolled in this experiment thus far?
"Affirmative. The information displayed on clinicaltrials.gov attests to the fact that this medical trial, initially posted on October 4th 2019 is currently accepting candidates. A total of 24 participants need to be sourced from a single location."
Are there any precedential investigations that have employed Cyclophosphamide?
"As of now, Cyclophosphamide has 952 live clinical trials with 169 in Phase 3. Philadelphia, Pennsylvania is the epicentre for this drug's research but it is being tested at 29684 sites across the world."
What are the deleterious effects of Cyclophosphamide usage?
"Our team at Power gave Cyclophosphamide a score of 1 as this is still in the early stages of testing. Data corroborating its safety and efficacy has not been fully established yet."
What are the chief objectives of this medical experiment?
"Over the course of four weeks, this trial will measure adverse events and secondary outcomes including CAR T-cell 19/20 bispecific transgenic cell persistence, progression-free survival, and clinical response. Descriptive statistics such as mean, standard deviation, median etc., figures with Kaplan Meier estimates along with suitable plots for longitudinal data will be used to analyse these parameters."
Are my credentials suitable for enrollment in this research?
"This study requires 24 participants who have suffered a relapse, aged 18 to 70. Qualifications include possessing one of the following conditions: DLBCL, PMBCL, MCL, FL, CLL or SLL that is resistant to standard treatments and having an ECOG performance status between 0-1."
Are geriatric patients receiving treatments in this research study?
"This medical research endeavour is open to persons aged 18 and above, but below the age of 70."
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