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CART19 for Acute Lymphoblastic Leukemia
Study Summary
This trial is testing a new cancer treatment called CART19 on patients with different types of leukemia. The goal is to see if it is effective, especially in patients who have not responded to other treatments.
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 have not had brain radiation or bone marrow transplant for my current CNS relapse.My leukemia cells test positive for CD19.I have B-cell Acute Lymphoblastic Leukemia that is CD19 positive.I am HIV positive.I do not have any ongoing infections that aren’t responding to treatment.I am between 0 and 29 years old.My kidney function, based on my age and gender, meets the required levels.My brain condition is worsening despite treatment, or I have brain lesions that could make treatment risky.I am currently receiving treatment for active graft-versus-host disease.I am using or might need steroids during my treatment, except for inhaled or low-dose ones.I have active hepatitis B or C.
- Group 1: Subjects with hypodiploid B-ALL
- Group 2: Subjects with t(17;19) B-ALL
- Group 3: Infant subjects with very high risk KMT2A B-ALL
- Group 4: Subjects with central nervous system (CNS) relapse
- 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
Who meets the screening criteria for this trial?
"This particular study is enrolling 27 individuals with a history of bone cancer who are between 0 and 29 years old. It's important to note that candidates must meet the following additional requirements: 1.7 1.4, c.Cohort D: Subjects in a first or greater CNS relapse, prior to therapy with cranial XRT or HSCT for the current relapse, Age 0 to 29 years, ≥ 16 years , c.Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and < Grade 3 hypoxia; DLCO ≥ 40% (corrected for anemia) if PFTs"
Has the FDA issued a statement on Murine CART19?
"Murine CART19 clinical trial is in Phase 2, meaning that while there is some evidence to support the safety of this medication, its efficacy has yet to be proven."
Has a trial like this been conducted before?
"Currently, there are 18 ongoing clinical trials for Murine CART19 in 115 cities and 22 countries. The first trial began in 2015 and was sponsored by Novartis Pharmaceuticals. That initial study had 97 patients and completed Phase 2 drug approval. In the 5 years since the first study, 11 more have been completed."
How many individuals are signing up to participate in this research project?
"This trial is no longer looking for new participants. According to the clinicaltrials.gov listing, which was last updated on 1/11/2022, this study is now closed to enrolment. There are 1076 other trials currently underway that focus on bone marrow and 18 additional studies searching for patients with Murine CART19."
Does this experiment have an age limit?
"According to the inclusion criteria, patients that meet the requirements for this trial must be between 0 and 29 years old. In addition, there are 175 studies for patients under 18 and 958 for senior citizens aged 65 or older."
Are there any unfilled slots in this research project?
"This study is not open for recruitment at the moment. The trial was first posted on March 12th 2020 and updated January 11th 2022. For other studies, there are 1076 trials actively searching for patients with bone related issues and 18 Murine CART19 studies enrolling patients."
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