Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060671
Status:
TERMINATED
Last Update Posted:
2015-01-19
First Post:
2003-05-09
Brief Title:
Comparative Trial for Pixantrone in Combination With Rituximab in Indolent Non-Hodgkins Lymphoma
Sponsor:
CTI BioPharma
Organization:
CTI BioPharma
Study Overview
Official Title:
An Open-Label Randomized Phase III Comparative Trial of BBR 2778 Rituximab Versus Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkins Lymphoma NHL
Status:
TERMINATED
Status Verified Date:
2013-05
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:
None
Brief Summary:
The purpose of this study is to determine whether combining pixantrone BBR 2778 INN name pending with the monoclonal antibody rituximab leads to an increase in the period of patients remission compared to rituximab alone
Detailed Description:
This trial is being conducted in patients with indolent or low-grade non-Hodgkins lymphoma who have either relapsed or been refractory to previous treatment
Pixantrone belongs to the DNA intercalator family of chemotherapy agents which includes anthracyclines DNA intercalators are commonly used to treat patients with indolent NHL often in combination with the monoclonal antibody rituximab This study represents the first large-scale comparative trial in indolent NHL designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a DNA intercalator is significantly higher than seen in patients treated with rituximab alone
This trial is randomized and controlled which means that participating patients will be randomly assigned to one of two treatment groups
1 Patients treated with both pixantrone and rituximab in combination
2 Patients treated with only rituximab
This trial is expected to recruit around 800 patients in the US Europe and Israel with 400 patients recruited to each group
Patients will be treated for around 18 weeks and will recieve regular physician monitoring for five years from the end of treatment
Pixantrone belongs to the DNA intercalator family of chemotherapy agents which includes anthracyclines DNA intercalators are commonly used to treat patients with indolent NHL often in combination with the monoclonal antibody rituximab This study represents the first large-scale comparative trial in indolent NHL designed to determine whether the response rate and time to tumour progression in patients treated with a combination of rituximab and a DNA intercalator is significantly higher than seen in patients treated with rituximab alone
This trial is randomized and controlled which means that participating patients will be randomly assigned to one of two treatment groups
1 Patients treated with both pixantrone and rituximab in combination
2 Patients treated with only rituximab
This trial is expected to recruit around 800 patients in the US Europe and Israel with 400 patients recruited to each group
Patients will be treated for around 18 weeks and will recieve regular physician monitoring for five years from the end of treatment
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