Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120198
Status:
TERMINATED
Last Update Posted:
2007-11-16
First Post:
2005-07-08
Brief Title:
Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkins Lymphoma Patients
Sponsor:
Geriatric Oncology Consortium
Organization:
Geriatric Oncology Consortium
Study Overview
Official Title:
A Pilot Study of CyclophosphamidePegylated Liposomal DoxorubicinVincristinePrednisone CDOP Plus Rituximab for Treatment of Elderly Patients With Previously Untreated Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Currently there is no one standard of care for older patients with Non-Hodgkins Lymphoma NHL The study will examine the tolerability and feasibility to the combination of Cyclophosphamide Pegylated Liposomal Doxorubicin Vincristine Prednisone CDOP plus Rituximab
Detailed Description:
Elderly NHL patients tend to tolerate the combination of cyclophosphamide doxorubicin vincristine and prednisone CHOP less well when compared to the younger population Cardiotoxicity as well as neutropenia are the most common side effects in the elderly population with age being a risk factor for doxorubicin induced cardiac toxicity Treatment related toxicity in the older population can preclude adequate therapy and potentially contribute to poor outcomes Pegylated liposomal doxorubicin has shown similar efficacy with a significant lower incidence of cardiotoxicity ad significantly fewer cardiac events compared with conventional doxorubicin Exploration of alternative regimens to maximize tolerability and thus enhance overall efficacy in this population is warranted Both safety and efficacy will be evaluated
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