Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278538
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2006-01-15
Brief Title:
Cyclophosphamide and Rabbit Antithymocyte Globulin rATGRituximab in Patients With Systemic Lupus Erythematosus
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Cyclophosphamide and rATGRituximab in Patients With Systemic Lupus Erythematosus Phase II Trial
Status:
COMPLETED
Status Verified Date:
2019-11
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 is designed to examine whether treating patients with lupus with high dose cyclophosphamide together with rATGrituximab drugs which reduce the function of the immune system followed by return of their previously collected stem cells will result in improvement in the disease Stem cells are undeveloped cells that have the capacity to grow into mature blood cells which normally circulate in the blood stream The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body The study purpose is to examine whether this treatment will result in improvement in the lupus disease
Detailed Description:
Mobilization Participants will be administered Cyclophosphamide at 20 gm2 in 200 ml of normal saline NS over 1 hour Hydration with 09 NS at approximately 100-250-ml hour will begin 4 hours prior to cyclophosphamide and continued for 24 hours after termination of cyclophosphamide Urine output approximately greater than 100 mlhour should be maintained
Granulocyte-colony stimulating factor G-CSF will be administered subcutaneously at 5-10 mcgkgday and will be started 5 days after termination of cyclophosphamide administration
After the absolute neutrophil count is greater than 1000ul or after hematological nadir leukapheresis using a continuous flow blood cell separator will be initiated A 10-15 liter apheresis will be performed unless stopped earlier for clinical judgment of toxicity eg numbness tetany The G-CSF will continue until apheresis is discontinued If necessary platelets will be transfused to greater than 60000ul prior to each apheresis
Conditioning Regimen Mesna 50mgkgday x 4 days will be given intravenously over 24 hours
Cyclophosphamide 50 mgkgday x 4 days the lesser of ideal or actual weight will be given intravenously over 1 hour in 250 cc of normal saline on days -5 through -2
Hydration approximately 50-200cchour in adults should begin 6 hours before cyclophosphamide and continue until 24 hours after the last cyclophosphamide dose Hydration rates need to be individually adjusted by daily weights to maintain dry weight count Twice daily weights will be obtained Warning Participants with renal insufficiency are prone to volume overload Early institution of ultrafiltration or dialysis is recommended
rATG 05mgkg will be given IV on day -5 10mgkg will be given on day
-4 15mgkg will be given IV on days -3 -2 -1 no dose adjustment It will be given over 10 hours Premedicate with Solumedrol 250mg IV acetaminophen 650mg po qd and diphenhydramine 25mg 30 minutes before infusion
Rituximab 500mgday will be given IV on days -6 and 1 At the first dose D-6 rituximab infusion will be started at 50mgh and escalate the infusion rate by 50mg every 30minutes to a maximum of 400mgh Starting the second dose days -4 -2 and 1 IV infusion will be started at 100mgh and escalate the infusion rate 100mg every 30minutes to a maximum of 400mgh Premedicate with Solumedrol 250mg IV acetaminophen 650mg po qd and diphenhydramine 25mg 30 minutes before infusion on days -6 and 1 Premedicate acetaminophen 650mg po qd and diphenhydramine 25mg 30 minutes before infusion on days -4 and -2
Stem Cell Reinfusion Previously collected stem cells will be reinfused on day 0 as noted in Table 4 The stem cells are infused over approximately 20 minutes through the central venous catheter such as a peripherally inserted central catheter PICC line Following stem cell reinfusion routine daily labs will be obtained including complete blood count CBC chemistry panel and liver function tests Antibiotics and blood transfusions will be administered as required by clinical judgment
Granulocyte-colony stimulating factor G-CSF will be administered subcutaneously at 5-10 mcgkgday and will be started 5 days after termination of cyclophosphamide administration
After the absolute neutrophil count is greater than 1000ul or after hematological nadir leukapheresis using a continuous flow blood cell separator will be initiated A 10-15 liter apheresis will be performed unless stopped earlier for clinical judgment of toxicity eg numbness tetany The G-CSF will continue until apheresis is discontinued If necessary platelets will be transfused to greater than 60000ul prior to each apheresis
Conditioning Regimen Mesna 50mgkgday x 4 days will be given intravenously over 24 hours
Cyclophosphamide 50 mgkgday x 4 days the lesser of ideal or actual weight will be given intravenously over 1 hour in 250 cc of normal saline on days -5 through -2
Hydration approximately 50-200cchour in adults should begin 6 hours before cyclophosphamide and continue until 24 hours after the last cyclophosphamide dose Hydration rates need to be individually adjusted by daily weights to maintain dry weight count Twice daily weights will be obtained Warning Participants with renal insufficiency are prone to volume overload Early institution of ultrafiltration or dialysis is recommended
rATG 05mgkg will be given IV on day -5 10mgkg will be given on day
-4 15mgkg will be given IV on days -3 -2 -1 no dose adjustment It will be given over 10 hours Premedicate with Solumedrol 250mg IV acetaminophen 650mg po qd and diphenhydramine 25mg 30 minutes before infusion
Rituximab 500mgday will be given IV on days -6 and 1 At the first dose D-6 rituximab infusion will be started at 50mgh and escalate the infusion rate by 50mg every 30minutes to a maximum of 400mgh Starting the second dose days -4 -2 and 1 IV infusion will be started at 100mgh and escalate the infusion rate 100mg every 30minutes to a maximum of 400mgh Premedicate with Solumedrol 250mg IV acetaminophen 650mg po qd and diphenhydramine 25mg 30 minutes before infusion on days -6 and 1 Premedicate acetaminophen 650mg po qd and diphenhydramine 25mg 30 minutes before infusion on days -4 and -2
Stem Cell Reinfusion Previously collected stem cells will be reinfused on day 0 as noted in Table 4 The stem cells are infused over approximately 20 minutes through the central venous catheter such as a peripherally inserted central catheter PICC line Following stem cell reinfusion routine daily labs will be obtained including complete blood count CBC chemistry panel and liver function tests Antibiotics and blood transfusions will be administered as required by clinical judgment
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