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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456023
Recruitment Status : Withdrawn (This study was cancelled before enrolling any patients for business related reasons.)
First Posted : July 2, 2020
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma (DLBCL) Biological: Tisagenlecleucel Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-arm, Multicenter Trial to Evaluate the Efficacy and Safety of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)
Estimated Study Start Date : January 31, 2022
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : September 27, 2027


Arm Intervention/treatment
Experimental: Tisagenlecleucel
All patients eligible for treatment with tisagenlecleucel will receive a single dose of tisagenlecleucel.
Biological: Tisagenlecleucel
A single intravenous (i.v.) infusion of 0.6 - 6.0×10^8 CAR positive viable T cells.
Other Name: CTL019




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months ]
    Complete Response (CR) and Partial Response (PR) according to the Lugano classification as determined by the Investigator.


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months ]
    Time from CR or PR, whichever occurs first, to relapse or death due to DLBCL.

  2. Time to response (TTR) [ Time Frame: From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months ]
    Time from tisagenlecleucel infusion to CR or PR, whichever occurs first.

  3. Progression-Free Survival (PFS) [ Time Frame: From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months ]
    Time from tisagenlecleucel infusion to the first documented disease progression or death due to any cause.

  4. Event free survival (EFS) [ Time Frame: From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months ]
    Time from tisagenlecleucel infusion to the first documented disease progression or relapse, new treatment for lymphoma or death due to any cause.

  5. Overall Survival (OS) [ Time Frame: From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months ]
    Time from tisagenlecleucel infusion to death due to any cause.

  6. Number of Participants with On-Treatments Adverse Events, Serious Adverse Events, and Deaths [ Time Frame: From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months ]
    Analysis of absolute and relative frequencies for treatment emergent AE, SAE and Deaths by primary System Organ Class (SOC) through the monitoring of relevant clinical and laboratory safety parameters.

  7. Tisagenlecleucel immunogenicity (humoral) [ Time Frame: Up to Month 60 ]
    The humoral immunogenicity assay will be evaluated to measure the antibody titers specific to the tisagenlecleucel molecule prior to and following infusion.

  8. Tisagenlecleucel immunogenicity (cellular) [ Time Frame: Up to Month 60 ]
    The cellular immunogenicity assay will be evaluated to assess the presence of T lymphocytes activated by the tisagenlecleucel protein.

  9. In vivo cellular PK profile of tisagenelecleucel [ Time Frame: Up to Month 60 ]
    qPCR and flow cytometry to measure tisagenlecleucel transgene concentration in blood, bone marrow and other matrices/tissues.

  10. Concentration of Tocilizumab PK in tocilizumab treated subjects during CRS [ Time Frame: Up to Day 7 after tocilizumab infusion ]
    Concentration of Tocilizumab

  11. Serum cytokines (IL-10, interferon gamma, IL-6, CRP and ferritin) [ Time Frame: Up to Month 60 ]
    Concentration of soluble factors (IL-10, interferon gamma, IL-6, CRP and ferritin) will be listed and summarized by participant and time point.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456023


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04456023    
Other Study ID Numbers: CCTL019C2203
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

URL: https://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diffuse Large B-cell Lymphoma
double/triple hit lymphoma
relapsed/refractory
tisagenlecleucel
CTL019
Chinese
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases