Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156013
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2005-09-08
Brief Title:
Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma NHL
Sponsor:
Oncology Specialists SC
Organization:
Oncology Specialists SC
Study Overview
Official Title:
A Phase III Open-label Study of Clofarabine in Patients With Relapsed or Refractory Diffuse Large Cell B-Cell NHL
Status:
COMPLETED
Status Verified Date:
2017-10
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:
This research is being done to develop new treatment for non-hodgkins lymphoma in subjects whose cancer has returned or resisted treatment with chemotherapy The investigational drug clofarabine is being used in this study An investigational drug is one that has not been approved by the United States Food and Drug Administration FDA
Detailed Description:
The safety profile of clofarabine appears acceptable within the target populations studied to date in the clinical studies with numerous responses observed in heavily pre-treated patients with relapsedrefractory ALL or AML Dose escalation of clofarabine in patients with solid tumors and lymphoproliferative disorders has been limited because grade 3 and 4 myelosuppression was considered acceptable in patients with acute leukemia provided that hematologic recovery occurred within 6 weeks of therapy and dose escalation has proceeded as high as 40 mgm2 in this patient population Furthermore no responses were observed in a recent trial in which patients with relapsed CLL were treated with clofarabine 2 mgm2 an indolent B-cell lymphoproliferative disorder indicating that low doses are likely to be ineffective in patients with aggressive NHL Personal Communication with ILEX Products INC
This Phase III study will evaluate escalating doses of clofarabine in patients with relapsed and refractory diffuse large cell B-cell NHL starting at a dose of 4 mgm2day for 5 consecutive days and repeated every 28 days for a maximum of 6 cycles This dosing regimen should be evaluated in this patient population because there is no standard therapy at relapse and grade 3 and 4 myelosuppression is frequently observed with traditional NHL salvage Additionally patients will receive granulocyte colony stimulating factors at the discretion of the investigator Antifungal and antibacterial prophylaxis will be administered to minimize the risk of infection
This Phase III study will evaluate escalating doses of clofarabine in patients with relapsed and refractory diffuse large cell B-cell NHL starting at a dose of 4 mgm2day for 5 consecutive days and repeated every 28 days for a maximum of 6 cycles This dosing regimen should be evaluated in this patient population because there is no standard therapy at relapse and grade 3 and 4 myelosuppression is frequently observed with traditional NHL salvage Additionally patients will receive granulocyte colony stimulating factors at the discretion of the investigator Antifungal and antibacterial prophylaxis will be administered to minimize the risk of infection
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