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

Phase 1

• Conditions: All patients who have been treated with chimeric antigen receptor (CAR) T-cell therapy in the context of a prior Novartis sponsored or supported study for any indication.; MedDRA version: 21.0Level: PTClassification code 10003917Term: B-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: 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-SE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-20
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1.Patients must have received CAR-T therapy within one of the following:
• Novartis or Penn sponsored CAR-T treatment trials where CAR-T was given as monotherapy or as combination therapy.
• Novartis managed access programs outside of the commercial setting, i.e. where CAR-T therapy was intended to be given in the setting of a Novartis or Penn sponsored CAR-T treatment trial
2.Patients must provide informed consent prior to their entry into this study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 255
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 472
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 173

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