Your session is about to expire
← Back to Search
CAR T-cell Therapy
Long-Term Follow-Up for CAR-T Therapy Safety (PAVO Trial)
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at m3 post treatment, m6, m9, m12 and every 6m up to year 5, yearly until year 15.
Awards & highlights
PAVO Trial Summary
This trial will follow people who have had CAR-T therapy for 15 years to assess any delayed adverse effects, monitor for RCL, and assess long-term efficacy.
Who is the study for?
This trial is for patients who have previously received CAR-T therapy and consented to long-term follow-up. It includes those who completed or left early from a Novartis-sponsored CAR-T study or a University of Pennsylvania CAR-T trial in collaboration with Novartis.Check my eligibility
What is being tested?
The study monitors the safety and effectiveness of CAR-T therapies over 15 years. It looks for delayed side effects, checks for virus that could replicate (RCL), and evaluates how well the treatment works over time including how long the vector lasts in the body.See study design
What are the potential side effects?
While this study doesn't introduce new treatments, it watches for late-occurring side effects from previous CAR-T therapy which can include immune system reactions, potential secondary cancers, or other gene therapy-related issues.
PAVO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at m3 post treatment, m6, m9, m12 and every 6m up to year 5, yearly until year 15.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at m3 post treatment, m6, m9, m12 and every 6m up to year 5, yearly until year 15.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients with certain events (see description)
Secondary outcome measures
B- and T- lymphocyte count
Height and weight, Tanner staging, menstruation status
Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death
+2 morePAVO Trial Design
1Treatment groups
Experimental Treatment
Group I: Previously treated CAR-T patientsExperimental Treatment1 Intervention
Patients who previously were exposed to lentiviral-based CART cell therapy
Find a Location
Who is running the clinical trial?
University of PennsylvaniaOTHER
2,005 Previous Clinical Trials
42,880,809 Total Patients Enrolled
Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,196,958 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously received a type of immunotherapy called CAR-T therapy in a Novartis-sponsored trial or a trial associated with the University of Pennsylvania that uses Novartis' CAR technology.Anyone can participate in this study, there are no specific reasons to exclude someone.
Research Study Groups:
This trial has the following groups:- Group 1: Previously treated CAR-T patients
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 individuals have received enrollment for this clinical experiment?
"Affirmative. The records found on clinicaltrials.gov demonstrate that this research endeavour, first publicized in November of 2015, is currently recruiting subjects. In total 1400 persons are expected to be enrolled from 24 different centres."
Answered by AI
Is there a way to enroll in the trial at this time?
"Indeed, according to clinicaltrials.gov, this medical trial is currently enrolling patients; the page was first posted on November 2nd 2015 and most recently revised on November 14th 2022. A total of 1400 participants need to be recruited across 24 different sites."
Answered by AI
How many distinct geographical sites are overseeing this experiment?
"Twenty-four medical centres are currently participating in this clinical trial, including Emory University School of Medicine/Winship Cancer Institute located in Atlanta, Childrens Hospital Los Angeles SC CTL019 found within Los Angelos, and the University of Michigan which is situated near Salt Lake City."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger