Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166439
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2005-09-12
Brief Title:
Trial of Oxaliplatin Cytosine Arabinoside Dexamethasone With Rituxan ROAD in Patients With Relapsed Non-Hodgkins Lymphoma
Sponsor:
Academic and Community Cancer Research United
Organization:
Academic and Community Cancer Research United
Study Overview
Official Title:
A Phase II Trial of Oxaliplatin Cytosine Arabinoside Dexamethasone With Rituxan ROAD in Patients With Relapsed CD20 B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-10
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 goals of this protocol are to determine the effect of oxaliplatin cytosine arabinoside and dexamethasone with Rituxan ROAD as treatment for patients with relapsed CD20 B-cell non-Hodgkins lymphoma NHL
Detailed Description:
Patients with B-cell NHL that comes back after chemotherapy are typically treated with cisplatin high-dose cytosine arabinoside and dexamethasone DHAP or other platinum-based treatments Recent studies have shown a 37 response rate in patients with large cell lymphoma to immunotherapy with Rituxan Patients 75 years old and in otherwise good health may be candidates for high dose therapy with stem cell rescue if they have disease that remains sensitive to chemotherapy Typically patients are administered 2 cycles of DHAP or ICE ifosfamide carboplatin and etoposide and if the disease responds they proceed to high-dose therapy with stem cell support Even patients not considered transplant candidates are also often treated with DHAP or ICE or other salvage regimens It is likely that the response rate with DHAP alone in patients eligible for transplant is 59 Recent studies have attempted to improve on the results from DHAP or ICE by combining them with rituxan NCCTG has just completed a phase II trial of R-DHAP Preliminary results of the R-ICE protocol indicate a higher response rate and longer time to progression than traditional ICE
The problem with DHAP and ICE is that they are associated with significant side effects and specifically with DHAP the cisplatin often causes kidney problems In fact some patients who are considered transplant eligible before DHAP may become transplant ineligible simply by the kidney side effects Clearly there is a need to improve the quality of life of patients undergoing treatment and to avoid the kidney problems
The problem with DHAP and ICE is that they are associated with significant side effects and specifically with DHAP the cisplatin often causes kidney problems In fact some patients who are considered transplant eligible before DHAP may become transplant ineligible simply by the kidney side effects Clearly there is a need to improve the quality of life of patients undergoing treatment and to avoid the kidney problems
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2328-04 | OTHER | Mayo Clinic IRB | None |
| MC0485 | OTHER | None | None |