CAR-T Long Term Follow Up (LTFU) Study (PAVO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02445222|
Recruitment Status : Recruiting
First Posted : May 15, 2015
Last Update Posted : April 10, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program||Genetic: Previously treated CAR-T patients||Not Applicable|
Patients are enrolled following completion or early discontinuation from a Novartis sponsored or supported study of CAR T-Cell treatment. Patients will be followed for 15 years post treatment from the last treatment. They will be monitored for safety and efficacy within the primary treatment protocols for the protocol defined duration. Patients can drop off treatment protocols at any time to enter this long term Follow up study. Patients discontinuing from the primary treatment protocols for any reason will be enrolled in this long term follow up (LTFU). This will allow collecting data on long term safety and efficacy (as applicable) as mandated by the health authorities of all patients treated with CAR-T therapy within the concept of a single protocol.
Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy|
|Actual Study Start Date :||November 2, 2015|
|Estimated Primary Completion Date :||February 22, 2036|
|Estimated Study Completion Date :||February 22, 2036|
Previously treated CAR-T patients
Patients who previously were exposed to lentiviral-based CART cell therapy
Genetic: Previously treated CAR-T patients
Lentiviral-based CAR-T cell therapy
- Percentage of patients with certain events (see description) [ Time Frame: at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15. ]The percentage of pts with listed categories: New secondary malignancies, new serious infection, new incidence of serious neurologic disorder, New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, New incidence of a hematologic disorder
- Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points [ Time Frame: at M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15. ]
- Percentage of patients with detectable RCL by VSV-G [ Time Frame: at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15 ]
- Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death [ Time Frame: at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15. ]
- B- and T- lymphocyte count [ Time Frame: at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15. ]
- Height and weight, Tanner staging, menstruation status [ Time Frame: at M3 post treatment then M6, M12 and every year until year 15. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 .
- There are no specific exclusion criteria for this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445222
|Contact: Novartis Pharmaceuticals||1-888-669-6682|
|Contact: Novartis Pharmaceuticals||+41613241111|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Responsible Party:||Novartis Pharmaceuticals|
|Other Study ID Numbers:||
2014-001673-14 ( EudraCT Number )
|First Posted:||May 15, 2015 Key Record Dates|
|Last Update Posted:||April 10, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|