Description:
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.
Title
- Brief Title: Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)
- 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)
Clinical Trial IDs
- ORG STUDY ID:
CCTL019C2203
- NCT ID:
NCT04456023
Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
Interventions
Drug | Synonyms | Arms |
---|
Tisagenlecleucel | CTL019 | Tisagenlecleucel |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Tisagenlecleucel | Experimental | All patients eligible for treatment with tisagenlecleucel will receive a single dose of tisagenlecleucel. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
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 |
Safety Issue: | |
Description: | Complete Response (CR) and Partial Response (PR) according to the Lugano classification as determined by the Investigator. |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | Time from CR or PR, whichever occurs first, to relapse or death due to DLBCL. |
Measure: | 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 |
Safety Issue: | |
Description: | Time from tisagenlecleucel infusion to CR or PR, whichever occurs first. |
Measure: | 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 |
Safety Issue: | |
Description: | Time from tisagenlecleucel infusion to the first documented disease progression or death due to any cause. |
Measure: | 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 |
Safety Issue: | |
Description: | Time from tisagenlecleucel infusion to the first documented disease progression or relapse, new treatment for lymphoma or death due to any cause. |
Measure: | Overall Survival (OS) |
Time Frame: | From first dosing (single administration, Day 1) up to End of Study Visit (EOS), an average of 60 Months |
Safety Issue: | |
Description: | Time from tisagenlecleucel infusion to death due to any cause. |
Measure: | 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 |
Safety Issue: | |
Description: | 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. |
Measure: | Tisagenlecleucel immunogenicity (humoral) |
Time Frame: | Up to Month 60 |
Safety Issue: | |
Description: | The humoral immunogenicity assay will be evaluated to measure the antibody titers specific to the tisagenlecleucel molecule prior to and following infusion. |
Measure: | Tisagenlecleucel immunogenicity (cellular) |
Time Frame: | Up to Month 60 |
Safety Issue: | |
Description: | The cellular immunogenicity assay will be evaluated to assess the presence of T lymphocytes activated by the tisagenlecleucel protein. |
Measure: | In vivo cellular PK profile of tisagenelecleucel |
Time Frame: | Up to Month 60 |
Safety Issue: | |
Description: | qPCR and flow cytometry to measure tisagenlecleucel transgene concentration in blood, bone marrow and other matrices/tissues. |
Measure: | Concentration of Tocilizumab PK in tocilizumab treated subjects during CRS |
Time Frame: | Up to Day 7 after tocilizumab infusion |
Safety Issue: | |
Description: | Concentration of Tocilizumab |
Measure: | Serum cytokines (IL-10, interferon gamma, IL-6, CRP and ferritin) |
Time Frame: | Up to Month 60 |
Safety Issue: | |
Description: | Concentration of soluble factors (IL-10, interferon gamma, IL-6, CRP and ferritin) will be listed and summarized by participant and time point. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- Diffuse Large B-cell Lymphoma
- double/triple hit lymphoma
- relapsed/refractory
- tisagenlecleucel
- CTL019
- Chinese
Last Updated
April 21, 2021