Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060684
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2003-05-09
Brief Title:
Dose Ranging Trial for Pixantrone in the FND-R Variant Regimen in Indolent Non-Hodgkins Lymphoma
Sponsor:
CTI BioPharma
Organization:
CTI BioPharma
Study Overview
Official Title:
A Phase I Trial of BBR 2778 in Combination With Fludarabine Dexamethasone and Rituximab in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combinations safety and activity profile
Detailed Description:
The FND-R regimen is commonly used in the treatment of indolent Non-Hodgkins lymphoma NHL and contains the chemotherapy agents mitoxantrone fludarabine dexamethasone a steroid and the monoclonal antibody rituximab In this trial we are replacing mitoxantrone with pixantrone an agent with a similar chemical structure both agents are DNA intercalators The trial is being run in patients with relapsed or refractory indolent NHL and aims to define the appropriate dose of pixantrone to be used in this combination as well as to obtain data on pixantrones safety and activity profile in combination with these drugs
This trial is expected to recruit up to 30 patients in the USA Patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration After that patients will receive physician check-ups every three months
This trial is expected to recruit up to 30 patients in the USA Patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration After that patients will receive physician check-ups every three months
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