Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093587
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2004-10-06
Brief Title:
Antithymocyte Globulin and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Chemotherapy With or Without Radiation Therapy Followed By Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Trial of Two Dose Levels of Thymoglobulin as Part of a Myeloablative-Conditioning for a HLA Identical Matched Related Donor MRD Stem Cell Transplant With Cyclosporine CsA as Posttransplant Graft vs Host Disease GvHD Prophylaxis
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells It also helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving antithymocyte globulin before transplant and cyclosporine after transplant may stop this from happening
PURPOSE This randomized clinical trial is studying how well giving antithymocyte globulin together with cyclosporine works in preventing graft-versus-host disease in patients who are undergoing chemotherapy with or without radiation therapy followed by donor stem cell transplant for acute lymphoblastic leukemia or acute myeloid leukemia
PURPOSE This randomized clinical trial is studying how well giving antithymocyte globulin together with cyclosporine works in preventing graft-versus-host disease in patients who are undergoing chemotherapy with or without radiation therapy followed by donor stem cell transplant for acute lymphoblastic leukemia or acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Compare the incidence of acute graft-vs-host disease GVHD within the first 100 days after transplantation in patients with acute lymphoblastic leukemia or acute myeloid leukemia treated with a myeloablative conditioning regimen comprising cyclophosphamide with or without radiotherapy and low- vs high-dose anti-thymocyte globulin followed by allogeneic HLA-matched related stem cell transplantation and cyclosporine
Compare the incidence of serious adverse events within the first 100 days after transplantation in patients treated with these regimens
Secondary
Compare 100-day and 6-month survival in patients treated with these regimens
Compare the severity of acute GVHD in patients treated with these regimens
Compare the incidence of culture-proven infections at 100 days and 6 months after transplantation in patients treated with these regimens
Compare the incidence of mucositis in terms of presence severity and duration in patients treated with these regimens
Compare the number of days on opiate drugs within the first 30 days after transplantation in patients treated with these regimens
Compare the time to engraftment in patients treated with these regimens
Compare the incidence of hospitalization within the first 6 months after transplantation in terms of length of initial stay cumulative total days and number of hospitalizations in patients treated with these regimens
Compare the relapse rate and time to relapse in patients treated with these regimens
Compare the incidence and severity of chronic GVHD between 100 days and 6 months after transplantation in patients treated with these regimens
OUTLINE This is a pilot randomized open-label multicenter study
Conditioning All patients receive a standard myeloablative-conditioning regimen that contains cyclophosphamide IV over 2 hours per center regimen typically on days -6 to -3 Patients also undergo total body irradiation OR receive busulfan
Graft-versus-host disease GVHD prophylaxis as part of conditioning Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive low-dose anti-thymocyte globulin IV over 4-8 hours on days -3 to -1
Arm II Patients receive high-dose anti-thymocyte globulin IV over 4-8 hours on days -5 to -1
Allogeneic hematopoietic stem cell transplantation Patients in both arms undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0
Post-transplantation GVHD prophylaxis Patients in both arms receive cyclosporine IV over 1-4 hours or orally twice daily beginning on day -1 and continuing until approximately day 60 followed by tapering doses until day 180 in the absence of GVHD
Patients are followed at 7 14 21 30 100 and 180 days
PROJECTED ACCRUAL A total of 30-60 patients 15-30 per treatment arm will be accrued for this study
Primary
Compare the incidence of acute graft-vs-host disease GVHD within the first 100 days after transplantation in patients with acute lymphoblastic leukemia or acute myeloid leukemia treated with a myeloablative conditioning regimen comprising cyclophosphamide with or without radiotherapy and low- vs high-dose anti-thymocyte globulin followed by allogeneic HLA-matched related stem cell transplantation and cyclosporine
Compare the incidence of serious adverse events within the first 100 days after transplantation in patients treated with these regimens
Secondary
Compare 100-day and 6-month survival in patients treated with these regimens
Compare the severity of acute GVHD in patients treated with these regimens
Compare the incidence of culture-proven infections at 100 days and 6 months after transplantation in patients treated with these regimens
Compare the incidence of mucositis in terms of presence severity and duration in patients treated with these regimens
Compare the number of days on opiate drugs within the first 30 days after transplantation in patients treated with these regimens
Compare the time to engraftment in patients treated with these regimens
Compare the incidence of hospitalization within the first 6 months after transplantation in terms of length of initial stay cumulative total days and number of hospitalizations in patients treated with these regimens
Compare the relapse rate and time to relapse in patients treated with these regimens
Compare the incidence and severity of chronic GVHD between 100 days and 6 months after transplantation in patients treated with these regimens
OUTLINE This is a pilot randomized open-label multicenter study
Conditioning All patients receive a standard myeloablative-conditioning regimen that contains cyclophosphamide IV over 2 hours per center regimen typically on days -6 to -3 Patients also undergo total body irradiation OR receive busulfan
Graft-versus-host disease GVHD prophylaxis as part of conditioning Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive low-dose anti-thymocyte globulin IV over 4-8 hours on days -3 to -1
Arm II Patients receive high-dose anti-thymocyte globulin IV over 4-8 hours on days -5 to -1
Allogeneic hematopoietic stem cell transplantation Patients in both arms undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0
Post-transplantation GVHD prophylaxis Patients in both arms receive cyclosporine IV over 1-4 hours or orally twice daily beginning on day -1 and continuing until approximately day 60 followed by tapering doses until day 180 in the absence of GVHD
Patients are followed at 7 14 21 30 100 and 180 days
PROJECTED ACCRUAL A total of 30-60 patients 15-30 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GENZ-SMC-101-1026 | None | None | None |
| UCLA-0402009-01 | None | None | None |