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CD19 CART Long Term Follow Up (LTFU) Study

This study is currently recruiting participants.
Verified February 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02445222
First Posted: May 15, 2015
Last Update Posted: February 13, 2017
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.
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

Condition Intervention
Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy Genetic: Previously treated CART CD 19 patients

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 Directed CAR T-Cell Therapy

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Proportion of pts with listed categories:New malignancies, incidence/exacerbation of pre-existing neurologic disorder,New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder,New incidence of a hematologic disorder [ Time Frame: at M2 post treatment then M3, M6 and M12, every 6M up to year 5, yearly until year 15. ]

Secondary Outcome Measures:
  • Proportion of patients with detectable CD19 CAR transgene levels in peripheral blood by q-PCR at pre- specified post CD19 CART infusion time points [ Time Frame: at M2 post treatment then M3, M6 and M12, every 6M up to year 5, yearly until year 15 if CD19 CAR transgene is still detectable. ]
  • Proportion of patients with detectable RCL by VSV-G [ Time Frame: at M2 post treatment then M3, M6 and M12, every 6M up to year 5, yearly until year 15 if CD19 CAR transgene is still detected ]
  • Proportion 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 M2 post treatment then M3, M6 and M12, every 6M up to year 5, yearly until year 15. ]
  • Absolute B- and T- lymphocyte count [ Time Frame: at M3, M6, M12 post treatment then every year up to year 5, yearly until year 15 if the CD19 CAR transgene is detected. ]
  • Height and weight, Tanner staging, menstrual cycle status [ Time Frame: at M2 post treatment then M3, M6 and M12, every year up to year 5, yearly until year 15. ]

Estimated Enrollment: 500
Actual Study Start Date: November 2, 2015
Estimated Study Completion Date: September 5, 2036
Estimated Primary Completion Date: September 5, 2036 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Previously treated CART CD19 patients
Patients who previously were exposed to lentiviral-based CT19 directed CART cell therapy
Genetic: Previously treated CART CD 19 patients
Lentiviral-based CD19 directed CART cell therapy

Detailed Description:

Patients are enrolled following completion or early discontinuation from a Novartis sponsored or supported study of CD19 directed CAR T-Cell treatment and will be followed for 15 years post treatment from the last CD19 directed CAR T-Cell treatment. Patients will be monitored for safety and efficacy within the primary treatment protocols for the protocol defined duration. While every effort will be made to keep patients in follow-up within the respective treatment protocol itself, patients can drop off treatment protocols at any time. 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 CD19 CART therapy within the concept of a single protocol.

Collection of such long term effects of CD19 CART cell therapy will help to further define the risk-benefit profile of CD19 CART.

  Eligibility

Information from the National Library of Medicine

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, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who have received anti-CD19 directed CART therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CD19-directed CART cells or from any CD19 CART 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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

  Show 34 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
University of Pennsylvania
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02445222     History of Changes
Other Study ID Numbers: CCTL019A2205B
2014-001673-14 ( EudraCT Number )
First Submitted: May 1, 2015
First Posted: May 15, 2015
Last Update Posted: February 13, 2017
Last Verified: February 2017