Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081055
Status:
WITHDRAWN
Last Update Posted:
2014-12-04
First Post:
2004-04-07
Brief Title:
OTI-010 for Graft-Versus-Host Disease Prophylaxis in Treating Patients Who Are Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies
Sponsor:
Mesoblast International Sàrl
Organization:
Mesoblast Ltd
Study Overview
Official Title:
A Phase II Double-Blind Randomized Placebo-Controlled Study to Evaluate the Safety and Efficacy of OTI-010 in Subjects Who Receive HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies
Status:
WITHDRAWN
Status Verified Date:
2014-12
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:
RATIONALE OTI-010 may be effective for graft-versus-host disease prophylaxis prevention in patients who are undergoing donor peripheral stem cell transplantation for hematologic malignancies cancer of the blood or bone marrow
PURPOSE This randomized phase II trial is studying how well OTI-010 works in preventing graft-versus-host disease in patients who are undergoing donor peripheral stem cell transplantation for hematologic cancer
PURPOSE This randomized phase II trial is studying how well OTI-010 works in preventing graft-versus-host disease in patients who are undergoing donor peripheral stem cell transplantation for hematologic cancer
Detailed Description:
OBJECTIVES
Compare the safety and efficacy of OTI-010 vs placebo as graft-versus-host disease prophylaxis in patients with hematologic malignancies undergoing HLA-identical sibling matched peripheral blood stem cell transplantation
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age 18 to 34 vs 35 to 55 and donorrecipient gender female donormale recipient vs female donorfemale recipient vs male donorfemale recipient vs male donormale recipient
Conditioning regimen Patients receive cyclophosphamide IV once daily on days -5 and -4 and undergo total body irradiation twice daily on days -3 to -1 OR busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV once daily on days -3 and -2
Graft-versus-host disease prophylaxis Patients receive methotrexate IV on days 1 3 6 and 11 Patients also receive cyclosporine orally or IV over 1-4 hours twice daily beginning on day -1 and continuing for at least 6 months followed by a taper until 1 year after transplantation
OTI-010 therapy Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive placebo IV 4 hours before peripheral blood stem cell transplantation PBSCT on day 0
Arm II Patients receive OTI-010 IV 4 hours before PBSCT on day 0
Arm III Patients receive a higher dose of OTI-010 IV 4 hours before PBSCT on day 0
Allogeneic stem cell transplantation Patients undergo allogeneic PBSCT on day 0
Patients are followed at 18 weeks at 6 9 and 12 months every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 99 patients 33 per treatment arm will be accrued for this study within 5 months
Compare the safety and efficacy of OTI-010 vs placebo as graft-versus-host disease prophylaxis in patients with hematologic malignancies undergoing HLA-identical sibling matched peripheral blood stem cell transplantation
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age 18 to 34 vs 35 to 55 and donorrecipient gender female donormale recipient vs female donorfemale recipient vs male donorfemale recipient vs male donormale recipient
Conditioning regimen Patients receive cyclophosphamide IV once daily on days -5 and -4 and undergo total body irradiation twice daily on days -3 to -1 OR busulfan IV over 2 hours every 6 hours on days -7 to -4 and cyclophosphamide IV once daily on days -3 and -2
Graft-versus-host disease prophylaxis Patients receive methotrexate IV on days 1 3 6 and 11 Patients also receive cyclosporine orally or IV over 1-4 hours twice daily beginning on day -1 and continuing for at least 6 months followed by a taper until 1 year after transplantation
OTI-010 therapy Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive placebo IV 4 hours before peripheral blood stem cell transplantation PBSCT on day 0
Arm II Patients receive OTI-010 IV 4 hours before PBSCT on day 0
Arm III Patients receive a higher dose of OTI-010 IV 4 hours before PBSCT on day 0
Allogeneic stem cell transplantation Patients undergo allogeneic PBSCT on day 0
Patients are followed at 18 weeks at 6 9 and 12 months every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 99 patients 33 per treatment arm will be accrued for this study within 5 months
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 |
|---|---|---|---|
| CDR0000358809 | REGISTRY | PDQ Physician Data Query | None |
| UCLA-0303036 | None | None | None |