Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833114
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2021-02-10
Brief Title:
Polatuzumab Vedotin Plus Rituximab Ifosfamide Carboplatin and Etoposide Pola-R-ICE Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma DLBCL
Sponsor:
GWT-TUD GmbH
Organization:
GWT-TUD GmbH
Study Overview
Official Title:
Open-label Prospective Phase III Clinical Study to Compare Polatuzumab Vedotin Plus Rituximab Ifosfamide Carboplatin and Etoposide Pola-R-ICE With Rituximab Ifosfamide Carboplatin and Etoposide R-ICE Alone as Salvage Therapy in Patients With Primary Refractory or Relapsed Diffuse Large B-cell Lymphoma DLBCL
Status:
RECRUITING
Status Verified Date:
2023-10
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:
Pola-R-ICE
Brief Summary:
An open-label prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab ifosfamide carboplatin and etoposide Pola-R-ICE with rituximab ifosfamide carboplatin and etoposide R-ICE alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma DLBCL
Detailed Description:
The study is designed as an international multicenter open-label two-arm prospective phase III study to compare the treatment of polatuzumab vedotin plus rituximab ifosfamide carboplatin and etoposide Pola-R-ICE with the combination of rituximab ifosfamide carboplatin and etoposide R-ICE alone as salvage therapy in patients with primary refractory or relapsed DLBCL
The study will involve study sites in Germany UK Spain and Austria It is planned to include 324 patients who will be randomized 11 to receive either treatment in the experimental arm Pola-R-ICE or in the standard arm R-ICE to end up with 308 evaluable subjects for the randomized part of the trial Further 10 patients will be treated with Pola-R-ICE during the safety run-in phase
The study consists of a screeninginclusion visit three chemotherapy cycles an end-of - treatment visit EoT and follow-up visits For each subject the total duration of the study will be approximately 3 months of treatment plus at least 21 months follow-up The study will end when the last included patient will have passed the last follow-up visit LPLFU For the study as a whole the primary outcome will be evaluated when the last included patient will have completed the 21 months follow-up period or has left the study prematurely
For the study as a whole the primary outcome will be evaluated when the last included patient will have completed the 21 months follow-up period or has left the study prematurely
The study will involve study sites in Germany UK Spain and Austria It is planned to include 324 patients who will be randomized 11 to receive either treatment in the experimental arm Pola-R-ICE or in the standard arm R-ICE to end up with 308 evaluable subjects for the randomized part of the trial Further 10 patients will be treated with Pola-R-ICE during the safety run-in phase
The study consists of a screeninginclusion visit three chemotherapy cycles an end-of - treatment visit EoT and follow-up visits For each subject the total duration of the study will be approximately 3 months of treatment plus at least 21 months follow-up The study will end when the last included patient will have passed the last follow-up visit LPLFU For the study as a whole the primary outcome will be evaluated when the last included patient will have completed the 21 months follow-up period or has left the study prematurely
For the study as a whole the primary outcome will be evaluated when the last included patient will have completed the 21 months follow-up period or has left the study prematurely
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MO40599 GLA 2017-R2 | OTHER | Financier | None |