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Clinical Trials List

Protocol NumberCCTL019A2205B
NCT Number(ClinicalTrials.gov Identfier)NCT02445222
Active

2020-11-01 - 2035-05-31

Phase III

Recruiting1

ICD-10C82.00

Follicular lymphoma grade I, unspecified site

ICD-10C82.09

Follicular lymphoma grade I, extranodal and solid organ sites

ICD-10C82.10

Follicular lymphoma grade II, unspecified site

ICD-10C82.19

Follicular lymphoma grade II, extranodal and solid organ sites

ICD-10C82.20

Follicular lymphoma grade III, unspecified, unspecified site

ICD-10C82.29

Follicular lymphoma grade III, unspecified, extranodal and solid organ sites

ICD-10C82.30

Follicular lymphoma grade IIIa, unspecified site

ICD-10C82.39

Follicular lymphoma grade IIIa, extranodal and solid organ sites

ICD-10C82.40

Follicular lymphoma grade IIIb, unspecified site

ICD-10C82.49

Follicular lymphoma grade IIIb, extranodal and solid organ sites

ICD-10C82.50

Diffuse follicle center lymphoma, unspecified site

ICD-10C82.59

Diffuse follicle center lymphoma, extranodal and solid organ sites

ICD-10C82.60

Cutaneous follicle center lymphoma, unspecified site

ICD-10C82.69

Cutaneous follicle center lymphoma, extranodal and solid organ sites

ICD-10C82.80

Other types of follicular lymphoma, unspecified site

ICD-10C82.89

Other types of follicular lymphoma, extranodal and solid organ sites

ICD-10C82.90

Follicular lymphoma, unspecified, unspecified site

ICD-10C82.99

Follicular lymphoma, unspecified, extranodal and solid organ sites

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9202.00

Nodular lymphoma, unspecified site, extranodal solid organ sites

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

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator MING YAO Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

B-cell Non-Hodgkin Lymphoma

Objectives

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.

Test Drug

CTL019

Active Ingredient

tisagenlecleucel

Dosage Form

infusion

Dosage

0.6-6.0x10^8 CAR-positive viable T cells, 30-70mL

Endpoints

Primary Outcome Measures :
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


Secondary Outcome Measures :
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. ]

Inclution 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

Exclusion Criteria:

There are no specific exclusion criteria for this study.

The Estimated Number of Participants

  • Taiwan

    4 participants

  • Global

    700 participants

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