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

NCT04456023 | Withdrawn Phase 2

• 1 other identifier: CCTL019C2203
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

Diffuse Large B-cell Lymphoma; double/triple hit lymphoma; relapsed/refractory; tisagenlecleucel; CTL019; Chinese

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Complete Response (CR) and Partial Response (PR) according to the Lugano classification as determined by the Investigator.

  From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months

Secondary Outcomes (11)

• Duration of Response (DOR)

  From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months

• Time to response (TTR)

  From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months

• Progression-Free Survival (PFS)

  From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months

• Event free survival (EFS)

  From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months

• Overall Survival (OS)

  From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months

Study Arms (1)

Tisagenlecleucel

EXPERIMENTAL

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

Biological: Tisagenlecleucel

Interventions

Tisagenlecleucel BIOLOGICAL

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

Also known as: CTL019

Tisagenlecleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study
• Patients must be ≥18 years of age at the time of ICF signature
• Histologically confirmed DLBCL at last relapse (including DLBCL transformed from follicular lymphoma and double-triple hit lymphoma)
• 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
• ECOG performance status that is either 0 or 1 at screening
• 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
• Adequate organ function
• Must have a leukapheresis material of non-mobilized cells available for manufacturing

You may not qualify if:

• Prior treatment with anti-CD19 therapy, adoptive T cell therapy, or any prior gene therapy product
• 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.
• Eligible for and consenting to autologous HSCT
• Prior allogeneic SCT
• 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
• Active neurological autoimmune or inflammatory disorders (e.g. Guillain-Barre syndrome)
• Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to screening

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Related Publications (1)

• 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.

  PMID: 34515338 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

Interventions

tisagenlecleucel

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: January 31, 2022
• Primary Completion: October 31, 2022
• Study Completion (Estimated): September 27, 2027
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share