ong term follow-up study for patients who have been treated with lentivirus-based chimeric antigen receptor (CAR) T-Cell Therapy directed against CD19

Phase 1

Conditions: Patients who have been treated for a B cell hematological malignancy in a Novartis sponsored or supported study of CD19 directed CAR T-Cell treatment are enrolled in this study following completion or early discontinuation from the Novartis sponsored or supported study of CD19 directed CAR T-Cell treatment.
MedDRA version: 19.0Level: PTClassification code 10003917Term: B-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0Level: PTClassification code 10003899Term: B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-001673-14-NL

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

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 .

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

- There are no specific exclusion criteria for this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - 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). ;Secondary Objective: - Monitor the persistence of CD19 CAR transgene<br>- Monitor for replication competent lentivirus (RCL)<br>- Assess the long-term efficacy of CD19 CART;Primary end point(s): Proportion of patients with listed categories: <br>- New malignancies<br>- Incidence/exacerbation of pre-existing neurologic disorder<br>- New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder<br>- New incidence of a hematologic disorder;Timepoint(s) of evaluation of this end point: Time Frame: 3 monthly until year 1, 6 monthly until year 5, yearly until year 15. <br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Proportion of patients with detectable CD19 CAR transgene levels in peripheral blood by q-PCR at pre- specified post CD19 CART infusion time points <br> - Proportion of patients with detectable RCL by VSV-G <br>- Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry; Incidence of death.<br> - Absolute B- and T- lymphocyte count <br> - Height and weight, Tanner staging, menstrual cycle status ;Timepoint(s) of evaluation of this end point: Time Frame: 3 monthly until year 1, 6 monthly until year 5, yearly until year 15. <br>