Treatment for Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: at M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15.

Year 15
Height and weight, Tanner staging, menstruation status
Year 15
Percentage of patients with detectable RCL by VSV-G
Year 15
B- and T- lymphocyte count
Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death
Year 15
Inverse PCR
Year 15
Percentage of patients with certain events (see description)

Trial Safety

Trial Design

0 Treatment Group

1400 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at m3 post treatment, m6, m9, m12 and every 6m up to year 5, yearly until year 15.

Who is running the clinical trial?

University of PennsylvaniaOTHER
1,822 Previous Clinical Trials
41,114,823 Total Patients Enrolled
Novartis PharmaceuticalsLead Sponsor
2,698 Previous Clinical Trials
3,522,824 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients who have received a CAR-T therapy from Novartis and completed or discontinued early from a Novartis-sponsored treatment protocol that used CAR-T cells or from any CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement are included in this group.
People who agreed to be in a long-term study before participating in it.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.