Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224874
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-09-21
Brief Title:
Treatment for Acute Graft-Versus-Host Disease BMT CTN 0302
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Initial Systemic Treatment of Acute GVHD A Phase II Randomized Trial Evaluating Etanercept Mycophenolate Mofetil MMF Denileukin Diftitox ONTAK and Pentostatin in Combination With Corticosteroids BMT CTN 0302
Status:
COMPLETED
Status Verified Date:
2017-08
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:
The study is a randomized Phase II four arm treatment trial The primary purpose of the study is to define new agents with promising activity against acute graft-versus-host disease GVHD suitable for testing against corticosteroids alone in a subsequent Phase III trial
Detailed Description:
BACKGROUND
Acute graft-versus-host disease GVHD is the major complication of allogeneic hematopoietic stem cell HSC transplantation Acute GVHD produces significant morbidity and complicates patient management resulting in organ toxicity frequent infections malnutrition and substantial delay in recovery from transplantation Corticosteroids have been the primary therapy for acute GVHD for over three decades Various additional immunosuppressive strategies have been tested as GVHD therapy but neither anti-thymocyte globulin ATG CD5-immunotoxins IL-1 antagonists nor other agents have been demonstrably helpful in either control of GVHD symptoms or improvement in survival Published response rates of complete response CR to acute GVHD therapy with corticosteroids range from 25-41 These rates will be used as benchmarks for assessing efficacy of promising new agents New immunosuppressive agents and strategies are required to improve the management of GVHD and decrease the toxicities of the immunosuppressive regimens
DESIGN NARRATIVE
In this trial patients with newly diagnosed acute GVHD will be randomly assigned to receive corticosteroids plus one of four new agents etanercept MMF denileukin diftitox Ontak and pentostatin A control arm of only corticosteroids will not be employed Each agent will be assessed for safety and efficacy at least 35 complete remission CR rate at Day 28 of therapy can be expected from previously untreated patients
Acute graft-versus-host disease GVHD is the major complication of allogeneic hematopoietic stem cell HSC transplantation Acute GVHD produces significant morbidity and complicates patient management resulting in organ toxicity frequent infections malnutrition and substantial delay in recovery from transplantation Corticosteroids have been the primary therapy for acute GVHD for over three decades Various additional immunosuppressive strategies have been tested as GVHD therapy but neither anti-thymocyte globulin ATG CD5-immunotoxins IL-1 antagonists nor other agents have been demonstrably helpful in either control of GVHD symptoms or improvement in survival Published response rates of complete response CR to acute GVHD therapy with corticosteroids range from 25-41 These rates will be used as benchmarks for assessing efficacy of promising new agents New immunosuppressive agents and strategies are required to improve the management of GVHD and decrease the toxicities of the immunosuppressive regimens
DESIGN NARRATIVE
In this trial patients with newly diagnosed acute GVHD will be randomly assigned to receive corticosteroids plus one of four new agents etanercept MMF denileukin diftitox Ontak and pentostatin A control arm of only corticosteroids will not be employed Each agent will be assessed for safety and efficacy at least 35 complete remission CR rate at Day 28 of therapy can be expected from previously untreated patients
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 |
|---|---|---|---|
| 285 | OTHER | National Heart Lung and Blood Institute | httpsreporternihgovquickSearchU01HL069294-05 |
| BMT CTN 0302 | OTHER | None | None |
| U01HL069294-05 | NIH | None | None |