Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)

NCT ID: NCT04456023

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2027-09-27

Brief Summary

This is a multi-center, phase II study to evaluate the efficacy and safety of CTL019 in Chinese adult patients with relapsed or refractory DLBCL.

Detailed Description

Disease assessments will be performed at screening, after bridging, 1, 3, 6, 9 and 12 months after tisagenlecleucel infusion, and every 6 months in the second year, and annually up to 60 months after infusion. Efficacy will be assessed until progression; safety will be assessed throughout the study. A long term follow-up up to 15 years after CTL019 infusion will continue under a separate protocol (CCTL019A2205B)(NCT02445222).

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tisagenlecleucel

All patients eligible for treatment with tisagenlecleucel will receive a single dose of tisagenlecleucel.

Group Type: EXPERIMENTAL

Tisagenlecleucel

Intervention Type: BIOLOGICAL

A single intravenous (i.v.) infusion of 0.6 - 6.0×10\^8 CAR positive viable T cells.

Interventions

Tisagenlecleucel

A single intravenous (i.v.) infusion of 0.6 - 6.0×10\^8 CAR positive viable T cells.

Intervention Type: BIOLOGICAL

Other Intervention Names

CTL019

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study

2. Patients must be ≥18 years of age at the time of ICF signature

3. Histologically confirmed DLBCL at last relapse (including DLBCL transformed from follicular lymphoma and double-triple hit lymphoma)

4. Relapsed or refractory disease after at least 2 lines of systemic therapy, including anti-CD20 antibody and an anthracycline, or having failed or being ineligible for autologous HSCT

5. ECOG performance status that is either 0 or 1 at screening

6. Measurable disease at time of enrollment:

• Nodal lesions greater than 15 mm in the long axis, regardless of the length of the short axis or
• Extra nodal lesion (outside lymph node or nodal mass, but including liver and spleen) at least 10 mm in long and short axis

7. Adequate organ function

8. Must have a leukapheresis material of non-mobilized cells available for manufacturing

Exclusion Criteria

1. Prior treatment with anti-CD19 therapy, adoptive T cell therapy, or any prior gene therapy product

2. Primary mediastinal large B-cell lymphoma, EBV+ DLBCL, Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, T cell / histiocyte rich large B-cell lymphoma, primary cutaneous DLBCL.

3. Eligible for and consenting to autologous HSCT

4. Prior allogeneic SCT

5. Active CNS involvement by disease under study, except if the CNS involvement has been effectively treated (i.e. patient is asymptomatic) and local treatment was greater than 4 weeks before enrollment

6. Active neurological autoimmune or inflammatory disorders (e.g. Guillain-Barre syndrome)

7. Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

References

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

Reference Type: DERIVED

PMID: 34515338 (View on PubMed)

Other Identifiers

CCTL019C2203

Identifier Type: -

Identifier Source: org_study_id