Your session is about to expire
← Back to Search
CAR T-cell Therapy
CAR T-cell Therapy for Pediatric Leukemia & Lymphoma
Phase 1 & 2
Recruiting
Led By Vanessa Fabrizio, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance score (Lansky or Karnofsky) of 50% or better
Aged 31 days to 30 years (inclusive) at time of consent and enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will study a new cancer treatment that uses a person's own immune cells to target and kill cancer cells. The treatment will be given to patients who have been previously excluded from other trials, such as children with cancer.
Who is the study for?
This trial is for children and young adults aged 1 month to 25 years with B-cell Acute Lymphoid Leukemia or Non-Hodgkin's Lymphoma that has relapsed multiple times, failed standard treatments, or occurred after a bone marrow transplant. Participants must have CD19 expression and be able to perform daily activities at least half of the time.Check my eligibility
What is being tested?
The study tests a new CAR-T cell therapy targeting CD19 on cancer cells in pediatric patients. It aims to provide quicker access to treatment for those who've had limited options before, including kids with B-cell NHL or those experiencing their first relapse.See study design
What are the potential side effects?
Potential side effects may include severe immune reactions, difficulty breathing, organ inflammation, fever-like symptoms due to cytokine release syndrome (a common reaction where the body releases too many cytokines into the blood too quickly), and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most activities but need help with some.
Select...
I am between 31 days and 30 years old.
Select...
I cannot receive the standard CD19 CAR-T cell therapy.
Select...
My leukemia or lymphoma is B-cell type and tests positive for CD19.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities
Secondary outcome measures
Non-Relapse Mortality
Overall Survival
Relapse
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: II: Dose ExpansionExperimental Treatment1 Intervention
22-40 additional subjects treated at the RP2D, including those treated within the phase 1 portion of the trial.
Group II: I: Dose EscalationExperimental Treatment1 Intervention
First 3-21 subjects enrolled. Treated with escalating doses of therapy until the RP2D is determined.
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,476 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,804 Total Patients Enrolled
Vanessa Fabrizio, MDPrincipal InvestigatorChildren's Hospital Colorado
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can do most activities but need help with some.I have HIV or active Hepatitis B/C.My organs are too weak for certain cancer treatments.I have not had gene therapy or CAR-T cell treatment before.I do not have a severe infection that would make cancer treatment unsafe.I am between 31 days and 30 years old.I do not have active, uncontrolled brain leukemia or lymphoma before starting treatment.I am a man or a woman not pregnant or breastfeeding.I cannot receive the standard CD19 CAR-T cell therapy.My leukemia or lymphoma is B-cell type and tests positive for CD19.I am eligible for or have already undergone a leukapheresis procedure.I am not pregnant, planning to become pregnant, or I agree to use birth control during the study.I am experiencing symptoms of Graft-versus-Host Disease.
Research Study Groups:
This trial has the following groups:- Group 1: II: Dose Expansion
- Group 2: I: Dose Escalation
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited for this clinical experiment?
"Confirmed, the clinical trial is still open for enrollment. It was first posted on February 24th 2021 with its most recent update occurring November 9th 2022. The project hopes to enroll 50 individuals from 1 medical centre."
Answered by AI
Does this research have any age restrictions?
"This medical trial is open to participants who are between 30 days and 25 years of age."
Answered by AI
Are there still vacancies to take part in this analysis?
"Yes, the clinicaltrials.gov website confirms that this research is actively trying to recruit individuals for participation. Initially posted on February 24th 2021 and recently modified on November 9th 2022, this medical trial seeks 50 participants at a single location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger