Relapsed or Refractory Follicular Lymphoma Clinical Trial
Official title:
A Global Randomized Multicenter Phase 3 Trial to Compare the Efficacy and Safety of Lisocabtagene Maraleucel (JCAR017/BMS-986387) to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (TRANSFORM FL)
The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.
| Status | Not yet recruiting |
| Enrollment | 300 |
| Est. completion date | October 16, 2031 |
| Est. primary completion date | October 16, 2031 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria - Participants must have measurable disease. - Participants must have previously been treated with certain defined anti-cancer therapies and their disease must have come back or must have not responded to the previous or last treatment. - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Participants that have histologically confirmed Follicular Lymphoma (FL) (Grade 1, 2, or 3a) corresponding to the most recent relapse prior to screening. - Participants that have Relapsed or refractory FL, as assessed by the Investigator. - Participants that have received at least one prior line and no more than three prior lines of systemic therapy including a combination of an anti-CD20 antibody and an alkylating agent. - Participants that received one prior line of systemic therapy are eligible if they present with high risk features. Exclusion Criteria - Participants must not have any history of heart problems. - Participants must not have any bleeding disorders. - Participants must not have any Central Nervous System involvement by Follicular Lymphoma or other brain conditions. - Other protocol-defined Inclusion/Exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Celgene Corporation |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival (PFS) | Defined as the time from randomization to death due to any cause or progressive disease (PD) per independent review committee (IRC) assessment using the Lugano 2014 Criteria, whichever occurs first | Up to 5 years from the last participant randomized | |
| Secondary | Complete response (CR) | Defined as participants achieving a complete response per IRC assessment using the Lugano 2014 Criteria | Up to 5 years from the last participant randomized | |
| Secondary | Overall survival (OS) | Defined as the time from randomization to death due to any cause | Up to approximately 7 years | |
| Secondary | Overall response (OR) | Defined as participants achieving a response (CR or partial response (PR)) per IRC assessment using the Lugano 2014 Criteria | Up to 5 years from the last participant randomized | |
| Secondary | Duration of response (DOR) | Defined as the time from first response (CR or PR) per IRC assessment using the Lugano 2014 Criteria to PD or death due to any cause, whichever occurs first | Up to 5 years from the last participant randomized | |
| Secondary | Event-free survival (EFS) | Defined as the time from randomization to the first documentation of progressive disease (PD) per IRC assessed using the Lugano 2014 Criteria start of new anti-cancer therapy, or death due to any cause, whichever occurs first | Up to 5 years from the last participant randomized | |
| Secondary | Time to next anti-cancer therapy (TTNLT) | Defined as time from randomization to start of new anti-cancer therapy or death due to any cause, whichever occurs first | Up to 5 years from the last participant randomized | |
| Secondary | PFS rate | Up to 5 years from the last participant randomized | ||
| Secondary | EFS rate | Up to 5 years from the last participant randomized | ||
| Secondary | OS rate | Up to approximately 7 years | ||
| Secondary | Progression-free survival on the next line of treatment (PFS-2) | Defined as the time from randomization to death from any cause or tumor progression on next line treatment per Investigator assessment, whichever occurs first | Up to 5 years from the last participant randomized | |
| Secondary | Number of participants with adverse events (AEs) | Up to 5 years from the last participant randomized | ||
| Secondary | Number of participants with adverse event of special interest (AESIs) | Up to 5 years from the last participant randomized | ||
| Secondary | Number of participants with serious adverse events (SAEs) | Up to 5 years from the last participant randomized | ||
| Secondary | Number of participants with laboratory abnormalities | Up to 5 years from the last participant randomized | ||
| Secondary | Frequency and length of hospitalizations | Up to 5 years from the last participant randomized | ||
| Secondary | Number of participants with intensive care unit (ICU) inpatient days | Up to 5 years from the last participant randomized | ||
| Secondary | Number of participants with non-ICU inpatient days | Up to 5 years from the last participant randomized | ||
| Secondary | Mean change from baseline in key health-related quality of life (HRQoL) domains. | Key HRQoL Domains:
Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20) |
Up to 5 years from the last participant randomized | |
| Secondary | Time to meaningful improvement/deterioration in key HRQoL domains. | Key HRQoL Domains:
Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20) |
Up to 5 years from the last participant randomized |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04712097 -
A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma
|
Phase 3 |