Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01994824
Status:
TERMINATED
Last Update Posted:
2023-11-30
First Post:
2013-11-20
Brief Title:
Preemptive Therapy of GVHD
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Preemptive Therapy of Graft-vs-Host Disease Using Rabbit Antithymocyte Globulin
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trend was observed toward higher mortality among the patients receiving the intervention Thymoglobulin on day 8 after hematopoietic cell transplantation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Graft-vs-host disease GVHD causes substantial mortality morbidity and poor quality of life after blood or marrow transplantation BMT In Alberta we use antithymocyte globulin ATG given on days -2 -1 and 0 in addition to methotrexate and cyclosporine for GVHD prophylaxis In spite of that 40 patients develop significant GVHD grade 2-4 acute GVHD or chronic GVHD needing systemic immunosuppressive therapy ATG at the dose we typically use 45 mgkg is relatively non-toxic At higher doses ATG could increase the likelihood of posttransplant infections or relapse Thus an extra dose of ATG on top of the routine 45 mgkg might be justified only for patients at high risk of developing significant GVHD In our experience low serum level of interleukin-15 IL15 and high serum level of interleukin-2 receptor alpha IL2Ra on day 7 predict development of significant GVHD Here we will test whether compared to historicalconcurrent controls an extra dose of ATG 3 mgkg on day 8 given to patients with low IL15 or high IL2Ra on day 7 reduces the incidence of significant GVHD and improves survival free of relapse and GVHD and quality of life
Detailed Description:
Blood for IL15 and IL2Ra determination will be drawn in the morning of day 7 10 ml red top tube IL15 and IL2Ra levels will be measured in StorekKhan Lab by enzyme-linked immunosorbent assay ELISA as described Pratt LM et al BMT 2013 StorekKhan Lab staff will report the IL15 and IL2Ra levels to the Bone Marrow Transplant ward Unit 57 Foothills Medical Centre no later than in the morning of day 8 If the IL15 level is 31 ngL or the IL2Ra level is 4500 ngL the physician caring for the patient on the ward will order Thymoglobulin 3 mgkg intravenously to be infused over 4-8 hours on day 8 The dose is based on actual body weight and is rounded to the nearest vial Thymoglobulin is supplied in 25 mg vials except if the rounding would result in 5 difference from the calculated dose Unit 57 standard practice will be followed for the infusion of ATG see Standard Operation Procedure BMTS40153 ATG Administration Premedication for ATG will include methylprednisolone 40 mg IVPB acetaminophen 1000 mg PO and diphenhydramine 50 mg IVPB Acetaminophen 1000 mg PO and diphenhydramine 50 mg IVPB can be repeated in 4-6 hours PRN flu-like symptomsfeverchills Meperidine 25-50 mg IVPB every 4 hours will be given PRN for rigors
EVALUATIONS For the endpoint of the incidence of significant GVHD patients will be followed per standard practice of the Alberta Blood and Marrow Transplant Program for the development of acute and chronic GVHD wwwalbertahealthservicescahpif-hp-cancer-guide-bmt-manualpdf Per this standard practice acute GVHD is graded according to Consensus criteria Przepiorka D BMT 1995 and chronic GVHD is diagnosed and graded according to NIH criteria Filipovich AH BBMT 2005 Significant GVHD is defined as grade 2-4 acute GVHD or chronic GVHD needing systemic immunosuppressive therapy
For the endpoint of survival free of significant GVHD and relapse relapse will be defined by standard criteria eg 5 marrow blasts by morphology in case of acute leukemia
For the endpoint of quality of life at 2 years 21-27 months posttransplant Short Form 36 will be used
EVALUATIONS For the endpoint of the incidence of significant GVHD patients will be followed per standard practice of the Alberta Blood and Marrow Transplant Program for the development of acute and chronic GVHD wwwalbertahealthservicescahpif-hp-cancer-guide-bmt-manualpdf Per this standard practice acute GVHD is graded according to Consensus criteria Przepiorka D BMT 1995 and chronic GVHD is diagnosed and graded according to NIH criteria Filipovich AH BBMT 2005 Significant GVHD is defined as grade 2-4 acute GVHD or chronic GVHD needing systemic immunosuppressive therapy
For the endpoint of survival free of significant GVHD and relapse relapse will be defined by standard criteria eg 5 marrow blasts by morphology in case of acute leukemia
For the endpoint of quality of life at 2 years 21-27 months posttransplant Short Form 36 will be used
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