Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031824
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2002-03-08
Brief Title:
Hydroxychloroquine in Treating Patients With Newly Diagnosed Chronic Graft-Versus-Host Disease
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Phase III Trial of Hydroxychloroquine Standard Therapy for Chronic Graft-Versus-Host Disease
Status:
COMPLETED
Status Verified Date:
2014-02
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 Hydroxychloroquine may decrease the immune response and be effective in treating chronic graft-versus-host disease It is not yet known if standard therapy for graft-versus-host disease is more effective with or without hydroxychloroquine
PURPOSE Randomized phase III trial to compare the effectiveness of standard therapy alone with that of standard therapy plus hydroxychloroquine in treating patients who have newly diagnosed chronic graft-versus-host disease
PURPOSE Randomized phase III trial to compare the effectiveness of standard therapy alone with that of standard therapy plus hydroxychloroquine in treating patients who have newly diagnosed chronic graft-versus-host disease
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of prednisone and cyclosporine with vs without hydroxychloroquine in patients with newly diagnosed extensive chronic graft-versus-host disease GVHD
Secondary
Compare the event-free and overall survival in patients treated with these regimens
Compare the health-related quality of life including longitudinal change in and magnitude of persistent disability in patients treated with these regimens
Correlate cytokine levels and T-helper cell subtypes with chronic GVHD activity and response in patients treated with these regimens
Correlate whole blood hydroxychloroquine levels with response and toxicity in patients treated with these regimens
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are randomized to one of two treatment arms
Patients may receive standard therapy comprising prednisone orally or IV 2-3 times daily or every other day and cyclosporine orally or IV twice daily or tacrolimus orally twice daily or IV by continuous infusion before randomization Patients not receiving cyclosporine or tacrolimus prior to randomization may receive cyclosporine or tacrolimus after randomization according to institutional preference
Arm I Within 10-14 days of beginning therapy with prednisone and cyclosporine or tacrolimus patients receive oral hydroxychloroquine twice daily
Arm II Patients receive standard therapy with prednisone and cyclosporine or tacrolimus as in arm I and oral placebo twice daily
In both arms treatment continues for 9 months in the absence of disease progression or unacceptable toxicity Patients with no response after 2 months of therapy are taken off study
Quality of life is assessed at baseline 1 month 9 months and 1 year
Patients are followed every month for 3 months and at 9 months
PROJECTED ACCRUAL A total of 232 patients 116 per treatment arm will be accrued for this study within 36 years
Primary
Compare the efficacy of prednisone and cyclosporine with vs without hydroxychloroquine in patients with newly diagnosed extensive chronic graft-versus-host disease GVHD
Secondary
Compare the event-free and overall survival in patients treated with these regimens
Compare the health-related quality of life including longitudinal change in and magnitude of persistent disability in patients treated with these regimens
Correlate cytokine levels and T-helper cell subtypes with chronic GVHD activity and response in patients treated with these regimens
Correlate whole blood hydroxychloroquine levels with response and toxicity in patients treated with these regimens
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are randomized to one of two treatment arms
Patients may receive standard therapy comprising prednisone orally or IV 2-3 times daily or every other day and cyclosporine orally or IV twice daily or tacrolimus orally twice daily or IV by continuous infusion before randomization Patients not receiving cyclosporine or tacrolimus prior to randomization may receive cyclosporine or tacrolimus after randomization according to institutional preference
Arm I Within 10-14 days of beginning therapy with prednisone and cyclosporine or tacrolimus patients receive oral hydroxychloroquine twice daily
Arm II Patients receive standard therapy with prednisone and cyclosporine or tacrolimus as in arm I and oral placebo twice daily
In both arms treatment continues for 9 months in the absence of disease progression or unacceptable toxicity Patients with no response after 2 months of therapy are taken off study
Quality of life is assessed at baseline 1 month 9 months and 1 year
Patients are followed every month for 3 months and at 9 months
PROJECTED ACCRUAL A total of 232 patients 116 per treatment arm will be accrued for this study within 36 years
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 |
|---|---|---|---|
| NCI-P02-0213 | Other Identifier | Childrens Cancer Group | None |
| COG-ASCT0031 | OTHER | None | None |
| CCG-S9701 | OTHER | None | None |