Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03960840
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2019-05-21
Brief Title:
Phase III Study of Rapcabtagene Autoleucel in CLL 3L DLBCL rr ALL and 1L HR LBCL
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Phase III Open Label Multicenter Study of Rapcabtagene Autoleucel in Adult Patients With CLLSLL 3L DLBCL rr ALL and 1L HR LBCL
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase III study to evaluate the feasibility safety and preliminary antitumor efficacy of rapcabtagene autoleucel also known as YTB323 Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia CLLsmall lymphocytic lymphoma SLL and as single agent in diffuse large B-cell lymphoma 3L DLBCL adult acute lymphoblastic leukemia ALL and 1st Line High Risk Large B-Cell Lymphoma 1L HR LBCL
Detailed Description:
This clinical trial is phase III open label multi-center study of rapcabtagene autoleucel
The Phase I part of the study comprises three independent treatment arms
Rapcabtagene autoleucel in combination with ibrutinib in adult CLLSLL participants with SD or PR after at least 6 months of second or subsequent line ibrutinib therapy As of 05-May-2021 this arm had completed enrollment
Rapcabtagene autoleucel single agent in adult DLBCL participants having failed two or more lines of chemotherapy and either having progressed or relapsed after autologous HSCT or being ineligible for or not consenting to the procedure
Rapcabtagene autoleucel single agent in adult relapsedrefractory ALL participants
The Phase II part of the study comprises two independent cohorts
Rapcabtagene autoleucel single agent in adult 3L DLBCL participants having failed two or more lines of chemoimmunotherapy and either having progressed or relapsed after autologous HSCT or being ineligible for or not consenting to the procedure This is an extension of the Phase I rr DLBCL treatment arm to support Phase II objectives
Rapcabtagene autoleucel single agent in newly diagnosed adult 1L HR LBCL participants defined as IPI 3-5 andor DHTH disease who have completed 2 cycles of CIT and have a response of PRSD with a Deauville score of 4-5
In the Phase I part of the trial the 3L DLBCL and ALL arms consist of two parts a dose escalation part to evaluate feasibility characterize safety and identify the recommended dose RD of rapcabtagene autoleucel and a dose expansion part to further characterize safety study rapcabtagene autoleucel cellular kinetics and assess preliminary antitumor activity Once the RD of rapcabtagene autoleucel is determined for each arm the corresponding expansion part will commence
In the Phase II part of the trial approximately 70 additional participants will be enrolled in a 3L DLBCL cohort treated at the recommended dose RD Including the 3L DLBCL participants who were treated at the RD from the Phase I part it is planned to have in total a cohort of approximately 100 participants included in the primary efficacy analysis based on the efficacy analysis set In addition a separate cohort in 1LHR LBCL will be included with approximately 50-60 participants planned for the primary efficacy analysis based on the efficacy analysis set
Participants will be followed under the current treatment protocol for safety and efficacy within this trial for a minimum of 2 years before being transferred to the long-term follow-up trial Once the study is complete participants will be enrolled in a post-study long term follow-up for lentiviral vector safety for up to 15 years This post-study long term follow-up for lentiviral vector safety will continue under a separate destination protocol
The Phase I part of the study comprises three independent treatment arms
Rapcabtagene autoleucel in combination with ibrutinib in adult CLLSLL participants with SD or PR after at least 6 months of second or subsequent line ibrutinib therapy As of 05-May-2021 this arm had completed enrollment
Rapcabtagene autoleucel single agent in adult DLBCL participants having failed two or more lines of chemotherapy and either having progressed or relapsed after autologous HSCT or being ineligible for or not consenting to the procedure
Rapcabtagene autoleucel single agent in adult relapsedrefractory ALL participants
The Phase II part of the study comprises two independent cohorts
Rapcabtagene autoleucel single agent in adult 3L DLBCL participants having failed two or more lines of chemoimmunotherapy and either having progressed or relapsed after autologous HSCT or being ineligible for or not consenting to the procedure This is an extension of the Phase I rr DLBCL treatment arm to support Phase II objectives
Rapcabtagene autoleucel single agent in newly diagnosed adult 1L HR LBCL participants defined as IPI 3-5 andor DHTH disease who have completed 2 cycles of CIT and have a response of PRSD with a Deauville score of 4-5
In the Phase I part of the trial the 3L DLBCL and ALL arms consist of two parts a dose escalation part to evaluate feasibility characterize safety and identify the recommended dose RD of rapcabtagene autoleucel and a dose expansion part to further characterize safety study rapcabtagene autoleucel cellular kinetics and assess preliminary antitumor activity Once the RD of rapcabtagene autoleucel is determined for each arm the corresponding expansion part will commence
In the Phase II part of the trial approximately 70 additional participants will be enrolled in a 3L DLBCL cohort treated at the recommended dose RD Including the 3L DLBCL participants who were treated at the RD from the Phase I part it is planned to have in total a cohort of approximately 100 participants included in the primary efficacy analysis based on the efficacy analysis set In addition a separate cohort in 1LHR LBCL will be included with approximately 50-60 participants planned for the primary efficacy analysis based on the efficacy analysis set
Participants will be followed under the current treatment protocol for safety and efficacy within this trial for a minimum of 2 years before being transferred to the long-term follow-up trial Once the study is complete participants will be enrolled in a post-study long term follow-up for lentiviral vector safety for up to 15 years This post-study long term follow-up for lentiviral vector safety will continue under a separate destination protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None