Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma (ELARA)

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: NCT03568461
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Results First Posted : July 22, 2022
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Biological: tisagenlecleucel Phase 2

Detailed Description:
This single-arm, open label study had the following sequential phases: Screening, Pretreatment, Treatment and Follow-up. In the Pre-treatment phase, the patient could undergo bridging therapy (optional) and lymphodepleting (LD) chemotherapy. Treatment and Follow-up Phase included tisagenlecleucel infusion, and safety and efficacy follow-up for at least 24 months. For all the patients who received tisagenlecleucel infusion, additional survival follow-up was to be performed to determine survival status every 3 months.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Actual Study Start Date : November 12, 2018
Actual Primary Completion Date : November 24, 2020
Estimated Study Completion Date : May 22, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CTL019
All patients who received tisagenlecleucel infusion.
 Biological: tisagenlecleucel
Tisagenlecleucel is single infusion.
Other Name: CTL019


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment [ Time Frame: 1 year ]
    Complete response rate was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) recorded from tisagenlecleucel infusion until progressive disease or start of new anticancer therapy, whichever came first. CRR was determined by an independent review committee (IRC) and was based on Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible response outcomes are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). PET response based on a 5-point scale (5PS) or Deauville score. The possible outcomes for PET response are complete metabolic response (CMR), partial metabolic response (PMR), no metabolic response (NMR), or progressive metabolic disease (PMD).


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) Per IRC Assessment [ Time Frame: 1 year ]
    Overall response rate is defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). Response was evaluated per Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible response outcomes are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). PET response based on a 5-point scale (5PS) or Deauville score. The possible outcomes for PET response are complete metabolic response (CMR), partial metabolic response (PMR), no metabolic response (NMR), or progressive metabolic disease (PMD).

  2. Duration of Response (DOR) Per IRC [ Time Frame: 1 year ]
    Duration of response (DOR) applied only to participants whose best overall disease response was CR or PR. It is defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to follicular lymphoma (FL).

  3. Progression Free Survival (PFS) [ Time Frame: 2 years ]
    Time from tisagenlecleucel infusion to first documented disease progression or death due to any cause

  4. Overall Survival (OS) [ Time Frame: 2 years ]
    Time from tisagenlecleucel infusion to death due to any cause

  5. Tisagenlecleucel Transgene Concentration [ Time Frame: 2 years ]
    Transgene concentration as detected by qPCR in target tissue

  6. Cmax; Cellular Kinetic Parameter of Tisagenlecleucel [ Time Frame: 2 years ]
    The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/ µg)

  7. Tmax; Cellular Kinetic Parameter of Tisagenlecleucel [ Time Frame: 2 years ]
    The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)

  8. AUC0-28; Cellular Kinetic Parameter of Tisagenlecleucel [ Time Frame: 2 years ]
    The AUC from time zero to day 28, in peripheral blood (%*days or days*copies/ µg)

  9. AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel [ Time Frame: 2 years ]
    The AUC from time zero to day 84, in peripheral blood (%*days or days*copies/ µg)

  10. T1/2; Cellular Kinetic Parameter of Tisagenlecleucel [ Time Frame: 2 years ]
    The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood

  11. Tlast; Cellular Kinetic Parameter of Tisagenlecleucel [ Time Frame: 2 years ]
    The last observed measureable timepoint after dose administration

  12. Summary of Exposure of CD3+ Tisagenlecleucel Cells in Peripheral Blood [ Time Frame: 2 years ]
    In vivo cellular kinetics of CD3+ tisagenlecleucel cells detected by flow cytometry

  13. Humoral Immunogenicity [ Time Frame: 2 years ]
    Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion.

  14. Cellular Immunogenicity [ Time Frame: 2 years ]
    Presence of T lymphocytes activated by the tisagenlecleucel protein

  15. Summary Scores of PRO Measured by SF-36v2 Quality of Life Questionnaire [ Time Frame: 2 years ]
    Effect of tisagenlecleucel therapy on Patient reported outcomes

  16. Summary Scores of PRO Measured by EQ-5D-3L Quality of Life Questionnaire [ Time Frame: 2 years ]
    Effect of tisagenlecleucel therapy on Patient reported outcomes

  17. Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire [ Time Frame: 2 years ]
    Effect of tisagenlecleucel therapy on Patient reported outcomes


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


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

Inclusion Criteria:

  • Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
  • Radiographically measurable disease at screening

Exclusion Criteria:

  • Evidence of histologic transformation
  • Follicular Lymphoma Grade 3B
  • Prior anti-CD19 therapy
  • Prior gene therapy
  • Prior adoptive T cell therapy
  • Prior allogeneic hematopoietic stem cell transplant
  • Active CNS involvement by malignancy

Other protocol-defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03568461


Locations
Show Show 30 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] March 29, 2018
Statistical Analysis Plan  [PDF] May 7, 2021

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03568461    
Other Study ID Numbers: CCTL019E2202
2017-004385-94 ( EudraCT Number )
First Posted: June 26, 2018    Key Record Dates
Results First Posted: July 22, 2022
Last Update Posted: November 3, 2022
Last Verified: November 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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
URL: https://www.clinicalstudydatarequest.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Refractory or relapsed Follicular Lymphoma
Refractory
Relapsed
Follicular lymphoma
CTL019
 Tisagenlecleucel
Chimeric antigen receptor
CAR19
CAR-T
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Tisagenlecleucel
Antineoplastic Agents, Immunological
Antineoplastic Agents