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CAR T-cell Therapy
CAR T Cell Therapy for Acute Lymphoblastic Leukemia
Phase 1
Recruiting
Led By Ibrahim Aldoss
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years
Awards & highlights
Summary
This trial tests a type of cancer treatment that changes a patient's immune cells in the lab to attack their cancer cells.
Who is the study for?
Adults aged 55 or older with B-cell acute lymphoblastic leukemia in first remission can join this trial. They must have a good performance status, proper liver and kidney function, and no severe infections like HIV or hepatitis. Women of childbearing age need a negative pregnancy test and agree to use birth control.
What is being tested?
The trial is testing the safety and optimal dose of modified T cells (CD19-CAR T cells) that are designed to target leukemia cells in older adults. It involves taking the patient's own immune cells, modifying them in a lab, growing large numbers, and infusing them back into the patient.
What are the potential side effects?
Potential side effects include reactions at infusion site, flu-like symptoms, fatigue, fever, headache, low blood pressure which could lead to dizziness or fainting; there may also be risk for more serious complications affecting different organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of cd19-car t cell infusion to the date of death or disease progression/relapse, whichever occurring first, assessed up to 15 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Incidence of dose-limiting toxicity (DLT)
Secondary study objectives
Event-free survival
Frailty phenotype score
Minimal residual disease (MRD) response rate
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CD19-CAR T cells)Experimental Treatment7 Interventions
Patients undergo T cell leukapheresis, receive fludarabine and cyclophosphamide IV, and then receive CD19-CAR T cell infusion IV on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2320
Fludarabine
2012
Completed Phase 4
~1860
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Marrow Aspiration and Biopsy
2016
Completed Phase 1
~40
Leukapheresis
2016
Completed Phase 2
~700
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,516 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,979 Total Patients Enrolled
Ibrahim AldossPrincipal InvestigatorCity of Hope Medical Cancer Center
2 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I tested negative for active hepatitis B.My brain or spinal cord cancer hasn't responded to specific treatments but is now in remission.I have a history of HIV or hepatitis B/C.I am not pregnant or breastfeeding.My heart condition severely limits my daily activities.My cancer is in its first full remission.I do not have plans for a transplant soon.I agree to use birth control or abstain from sex for 6 months after my last treatment dose.I am on medication for an autoimmune disease or GVHD.I must monitor my hepatitis B closely if I join the study and may need to start treatment.I have recovered from side effects of cancer treatment, except for hair loss.My kidneys are working well, as shown by tests.I do not have any uncontrolled serious illnesses.I am 55 years old or older.I am not on long-term steroids or immunosuppressants, except for low-dose or inhaled steroids.My cancer is in remission after initial treatment.I am mostly self-sufficient and can carry out daily activities.My leukemia cells tested positive for CD19 at diagnosis.I am a woman who can have children and my pregnancy test is negative.I am currently fighting an infection that needs antibiotics.I had cancer before, but it was either removed surgically with the aim of curing it, was a type of skin cancer, or has been inactive for 2+ years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CD19-CAR T cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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