Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074035
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2003-12-10
Brief Title:
Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease
Status:
COMPLETED
Status Verified Date:
2021-10
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:
RATIONALE Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells
PURPOSE This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory not responsive to treatment with steroids
PURPOSE This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory not responsive to treatment with steroids
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin
Secondary
Determine the time to next immunosuppressive agent ie the time to progression from best response in patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the infection rate in patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
Determine the changes in lymphocyte populations in patients treated with this drug
Determine the survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive pentostatin IV over 20-30 minutes on day 1 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients who achieve a complete response after 6 courses receive 4 additional courses Patients who achieve a partial response minor response or stable disease after 6 courses may receive up to 6 additional courses
Patients are followed every 4 weeks for 1 year every 3 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL Approximately 37 patients will be accrued for this study
Primary
Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin
Secondary
Determine the time to next immunosuppressive agent ie the time to progression from best response in patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the infection rate in patients treated with this drug
Determine the pharmacokinetics of this drug in these patients
Determine the changes in lymphocyte populations in patients treated with this drug
Determine the survival of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive pentostatin IV over 20-30 minutes on day 1 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients who achieve a complete response after 6 courses receive 4 additional courses Patients who achieve a partial response minor response or stable disease after 6 courses may receive up to 6 additional courses
Patients are followed every 4 weeks for 1 year every 3 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL Approximately 37 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000341678 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |