Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005778
Status:
COMPLETED
Last Update Posted:
2008-11-06
First Post:
2000-06-03
Brief Title:
High-Dose Intravenous IV Cyclophosphamide Versus Monthly IV Cyclophosphamide
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Randomized Trial of High-Dose IV Cyclophosphamide Versus Monthly IV Cyclophosphamide
Status:
COMPLETED
Status Verified Date:
2008-11
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 study compares the effectiveness of high-dose cyclophosphamide treatment with the gold standard treatment monthly intravenous IV cyclophosphamide in people with moderate to severe lupus that does not respond to high-dose corticosteroid therapy We will give patients either IV cyclophosphamide 750 milligrams per square meter of body surface area monthly for 6 months followed by quarterly maintenance therapy or high-dose IV cyclophosphamide 50 milligrams per kilogram body weight per day for the first four days of the study Patients will be followed for 24 months after therapy
Detailed Description:
Systemic lupus erythematosus SLE or lupus remains the prototypic autoimmune disease Recent data show that its incidence has tripled since 1970 and its prevalence is 1 in 800 in Rochester Minnesota The natural history of lupus in our cohort is one of 1 relapsing remitting or 2 chronic activity with only 17 percent of patients having periods of long quiescence Over 75 percent of our African-American patients and 50 percent of our Caucasian patients have renal kidney involvement Over 50 percent suffer permanent damage in one or more organ systems and over 15 percent have renal failure
Researchers at the National Institutes of Health NIH have shown that for patients with severe lupus especially with renal involvement monthly IV pulse cyclophosphamide 500 to 1000 mgm squared BSA for 6 months followed by quarterly maintenance for 2 years is superior to high-dose corticosteroid treatment NIH and others have shown that IV pulse cyclophosphamide is also effective for severe lupus in other organs However even monthly IV cyclophosphamide is not successful in all cases and it too has associated toxicity especially premature ovarian failure For that reason we have pioneered the use of high-dose immunoablative cyclophosphamide 200 mgkg in 10 patients with severe lupus refractory to other treatments
Because of the initial success of this approach including 75 percent complete response on no medications in renal lupus we are conducting a controlled trial of high-dose immunoablative cyclophosphamide versus the gold standard monthly IV cyclophosphamide in people with moderate to severe lupus refractory to high-dose corticosteroid therapy We will give patients either 750 mgm2 of body surface area IV cyclophosphamide monthly for 6 months followed by quarterly maintenance therapy we will readmit patients if necessary for infections or other complications or cyclophosphamide 50 mgkgd intravenously on days 1-4 We will calculate the dose of cyclophosphamide according to ideal body weight Patients are scheduled to receive only one course of therapy We will follow patients according to the infective guidelines for BMT
Researchers at the National Institutes of Health NIH have shown that for patients with severe lupus especially with renal involvement monthly IV pulse cyclophosphamide 500 to 1000 mgm squared BSA for 6 months followed by quarterly maintenance for 2 years is superior to high-dose corticosteroid treatment NIH and others have shown that IV pulse cyclophosphamide is also effective for severe lupus in other organs However even monthly IV cyclophosphamide is not successful in all cases and it too has associated toxicity especially premature ovarian failure For that reason we have pioneered the use of high-dose immunoablative cyclophosphamide 200 mgkg in 10 patients with severe lupus refractory to other treatments
Because of the initial success of this approach including 75 percent complete response on no medications in renal lupus we are conducting a controlled trial of high-dose immunoablative cyclophosphamide versus the gold standard monthly IV cyclophosphamide in people with moderate to severe lupus refractory to high-dose corticosteroid therapy We will give patients either 750 mgm2 of body surface area IV cyclophosphamide monthly for 6 months followed by quarterly maintenance therapy we will readmit patients if necessary for infections or other complications or cyclophosphamide 50 mgkgd intravenously on days 1-4 We will calculate the dose of cyclophosphamide according to ideal body weight Patients are scheduled to receive only one course of therapy We will follow patients according to the infective guidelines for BMT
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 |
|---|---|---|---|
| NIAMS-046 | None | None | None |