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Long-term follow-up for patients treated with CAR-T therapy

Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy

PHASE3 · Novartis · NCT02445222

This study is checking how safe and effective CAR-T therapy is for patients over 15 years after their treatment to see if there are any long-term side effects.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1400 (estimated)
Ages0 Years to 100 Years
SexAll
SponsorNovartis (industry)
Drugs / interventionsCAR-T, CAR T
Locations118 sites (Phoenix, Arizona and 117 other locations)
Trial IDNCT02445222 on ClinicalTrials.gov

What this trial studies

This study monitors patients who have received CAR-T therapy for long-term safety and efficacy over a period of 15 years following their last treatment. Patients enrolled in this follow-up will be those who completed or discontinued from a Novartis-sponsored CAR-T treatment protocol. The study aims to assess the risk of delayed adverse events and monitor for replication competent lentivirus, as well as evaluate long-term efficacy and vector persistence. Data collected will help define the risk-benefit profile of CAR-T therapies as mandated by health authorities.

Who should consider this trial

Good fit: Ideal candidates are patients who have previously received CAR-T therapy and completed or discontinued from a Novartis-sponsored treatment protocol.

Not a fit: Patients who have not received CAR-T therapy or are currently undergoing treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide crucial insights into the long-term safety and effectiveness of CAR-T therapies, improving patient management and treatment protocols.

How similar studies have performed: Other studies have shown the importance of long-term follow-up in gene therapies, indicating that this approach is both necessary and beneficial for understanding treatment outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* All patients who have received a CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology.
* Patients who have provided informed consent for the long term follow up study prior to their study participation .

Exclusion Criteria:

* There are no specific exclusion criteria for this study.

Where this trial is running

Phoenix, Arizona and 117 other locations

+68 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

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

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.