Ignite Creation Date:
2024-05-06 @ 12:52 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01679119
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2012-07-23
Brief Title:
Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
A Randomised Phase II Trial of Inotuzumab Ozogamicin Plus Rituximab CVP IO-R-CVP vs Gemcitabine Plus Rituximab CVP Gem-R-CVP for the First Line Treatment of Patients With DLBCL Who Are Not Suitable for Anthracycline Containing Chemotherapy
Status:
COMPLETED
Status Verified Date:
2022-05
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:
INCA
Brief Summary:
The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma DLBCL in a population of patients not suitable for anthracycline based chemotherapy
There is no standard of care for the treatment of this group of patients If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline R-CHOP
There is no standard of care for the treatment of this group of patients If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline R-CHOP
Detailed Description:
The incidence of DLBCL is increasing and with an expanding elderly population the incidence will continue to rise Given that about 40 of cases of DLBCL occur in patients aged over 70 and the number of co-mobilities increases with age research to investigate the optimal treatment of DLBCL in this group of patients is needed R-CHOP remains the standard of care for the majority of patients with DLBCL anthracycline use is precluded in a proportion of these patients by a high risk of developing cardiotoxicity especially congestive cardiac failure Currently there is no standard of care for patients who are unfit for anthracycline treatment It has been routine to omit the doxorubicin from R-CHOP giving R-CVP instead However the outcome for patients treated with R-CVP is poor and attempts have been made to replace the doxorubicin with alternative agents The trial will compare an experimental arm consisting of Inotuzumab Ozogamicin added to the standard immunochemotherapy regimen of rituximab cyclophosphamide vincristine and prednisolone R-CVP with the control arm of gemcitabine added to the same combination Gem-R-CVP
Study Oversight
Has Oversight DMC:
None
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?:
None