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Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT04456023

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

A Phase 2 study testing Tisagenlecleucel in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Novartis Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma (DLBCL)
What is being tested?
Tisagenlecleucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Jan 2022to 27 Sep 2027
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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

Who cannot join

  • 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

About this study

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)

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.

Read the 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).

Being tested
Tisagenlecleucel
Keywords
Diffuse Large B-cell Lymphoma, double/triple hit lymphoma, relapsed/refractory, tisagenlecleucel, CTL019, Chinese
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TisagenlecleucelBiological

    Also called CTL019

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

Study groups in NCT04456023
Study groupRoleWhat they receive
TisagenlecleucelExperimentalAll patients eligible for treatment with tisagenlecleucel will receive a single dose of tisagenlecleucel.
Receives: Biological: Tisagenlecleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

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

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

Secondary outcomes (11)

  1. Duration of Response (DOR)

    Time from CR or PR, whichever occurs first, to relapse or death due to DLBCL.

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

  2. Time to response (TTR)

    Time from tisagenlecleucel infusion to CR or PR, whichever occurs first.

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

  3. Progression-Free Survival (PFS)

    Time from tisagenlecleucel infusion to the first documented disease progression or death due to any cause.

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

  4. Event free survival (EFS)

    Time from tisagenlecleucel infusion to the first documented disease progression or relapse, new treatment for lymphoma or death due to any cause.

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

  5. Overall Survival (OS)

    Time from tisagenlecleucel infusion to death due to any cause.

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

  6. Number of Participants with On-Treatments Adverse Events, Serious Adverse Events, and Deaths

    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.

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

  7. Tisagenlecleucel immunogenicity (humoral)

    The humoral immunogenicity assay will be evaluated to measure the antibody titers specific to the tisagenlecleucel molecule prior to and following infusion.

    Measured: Up to Month 60

  8. Tisagenlecleucel immunogenicity (cellular)

    The cellular immunogenicity assay will be evaluated to assess the presence of T lymphocytes activated by the tisagenlecleucel protein.

    Measured: Up to Month 60

  9. In vivo cellular PK profile of tisagenelecleucel

    qPCR and flow cytometry to measure tisagenlecleucel transgene concentration in blood, bone marrow and other matrices/tissues.

    Measured: Up to Month 60

  10. Concentration of Tocilizumab PK in tocilizumab treated subjects during CRS

    Concentration of Tocilizumab

    Measured: Up to Day 7 after tocilizumab infusion

  11. Serum cytokines (IL-10, interferon gamma, IL-6, CRP and ferritin)

    Concentration of soluble factors (IL-10, interferon gamma, IL-6, CRP and ferritin) will be listed and summarized by participant and time point.

    Measured: Up to Month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2020
  2. Study start31 Jan 2022 (estimated)
  3. Primary completion31 Oct 2022 (estimated)
  4. Study completion27 Sep 2027 (estimated)

Why it stopped: This study was cancelled before enrolling any patients for business related reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04456023
Sponsor's protocol ID
CCTL019C2203
Status last verified
Feb 2022
First submitted
29 Jun 2020
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 34515338

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tisagenlecleucel in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Novartis Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04456023, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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