Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT02955628
Status:
UNKNOWN
Last Update Posted:
2017-02-14
First Post:
2016-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RICE-ibrutinib in Relapsed DLBCL
Sponsor:
Singapore General Hospital
Organization:
Study Overview
Official Title:
A Phase II Study of Ibrutinib With R-ICE Chemotherapy for Transplant-eligible Relapsed/Refractory Diffuse Large B-cell Lymphoma Followed by Ibrutinib Maintenance in Patients Not Achieving a Complete Response at Pre-transplant Interim Assessment
Status:
UNKNOWN
Status Verified Date:
2016-11
Last Known Status:
RECRUITING
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 multicentre, open-label, phase II study of ibrutinib 560 mg in combination with R-ICE for treatment of transplant-eligible relapsed/refractory diffuse large B-cell lymphoma.
Detailed Description:
All patients will receive R-ICE therapy for 2 cycles followed by PET-CT assessment (PET-2). Ibrutinib 560 mg will be added to the RICE regimen based on results of PET-2 as follows:
* Patients in CR will continue with 2 more cycles of R-ICE and proceed onto ASCT. These patients will not receive ibrutinib.
* In patients with stable disease or achieving a response that is less than CR, ibrutinib 560 mg will be added. The combination of ibrutinib-RICE will be given for 2 cycles and will be followed by PET-CT assessment (PET-4). Patients who achieve ≥ PR at this point will proceed onto ASCT.
* Patients who have disease progression will be removed from the trial. Hematopoietic stem cell harvesting can be performed following count recovery at any cycle of R-ICE, but preferably cycle 2.
Transplant conditioning regimen will be with standard BEAM chemotherapy (carmustine, etoposide, cytarabine, melphalan).
Following ASCT, ibrutinib will be given as maintenance therapy for patients who did not achieve a CR at the time of PET-2 assessment. This will be continued for up to 1 year after ASCT.
* Patients in CR will continue with 2 more cycles of R-ICE and proceed onto ASCT. These patients will not receive ibrutinib.
* In patients with stable disease or achieving a response that is less than CR, ibrutinib 560 mg will be added. The combination of ibrutinib-RICE will be given for 2 cycles and will be followed by PET-CT assessment (PET-4). Patients who achieve ≥ PR at this point will proceed onto ASCT.
* Patients who have disease progression will be removed from the trial. Hematopoietic stem cell harvesting can be performed following count recovery at any cycle of R-ICE, but preferably cycle 2.
Transplant conditioning regimen will be with standard BEAM chemotherapy (carmustine, etoposide, cytarabine, melphalan).
Following ASCT, ibrutinib will be given as maintenance therapy for patients who did not achieve a CR at the time of PET-2 assessment. This will be continued for up to 1 year after ASCT.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: