Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304018
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2006-03-15
Brief Title:
Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies
Status:
COMPLETED
Status Verified Date:
2013-08
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:
RATIONALE Giving chemotherapy such as fludarabine busulfan and etoposide before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer 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 tacrolimus and prednisone after transplant may stop this from happening
PURPOSE This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer
PURPOSE This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety and feasibility of performing donor umbilical cord blood transplantation UCBT in patients with advanced hematologic malignancies in terms of 80 engraftment rate at day 100 post-transplant and 50 transplant-related mortality
Secondary
Determine the toxicity of a myeloablative preparative regimen comprising busulfan fludarabine and etoposide prior to UCBT in these patients
Determine the neutrophil and platelet recovery in patients treated with this regimen
Determine the event-free and overall survival of patients treated with this regimen
Evaluate lineage-specific chimerism after UCBT and assess the contribution of each individual cord blood unit to post-transplantation hematopoiesis in these patients
Determine the incidence severity and timing of acute and chronic graft-vs-host disease in patients treated with this regimen
OUTLINE This is a pilot study
Preparative regimen Patients receive fludarabine IV over 30 minutes on days -7 to -3 busulfan IV over 2 hours 4 times daily on days -7 and -4 etoposide IV over 4 hours on day -3 and anti-thymocyte globulin IV over 6 hours on days -2 and -1
Donor umbilical cord blood transplantation UCBT Patients undergo donor UCBT on day 0 Beginning on day 7 patients receive sargramostim GM-CSF IV or subcutaneously once daily until blood counts recover
Graft-vs-host disease prophylaxis Patients receive tacrolimus IV continuously over 24 hours or orally twice daily beginning on day -2 and continuing until day 180 followed by a taper Patients also receive oral prednisone twice daily on days 13-50 and then once daily on days 50-60 followed by a rapid taper
After completion of study treatment patients are followed periodically for approximately 2 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Primary
Determine the safety and feasibility of performing donor umbilical cord blood transplantation UCBT in patients with advanced hematologic malignancies in terms of 80 engraftment rate at day 100 post-transplant and 50 transplant-related mortality
Secondary
Determine the toxicity of a myeloablative preparative regimen comprising busulfan fludarabine and etoposide prior to UCBT in these patients
Determine the neutrophil and platelet recovery in patients treated with this regimen
Determine the event-free and overall survival of patients treated with this regimen
Evaluate lineage-specific chimerism after UCBT and assess the contribution of each individual cord blood unit to post-transplantation hematopoiesis in these patients
Determine the incidence severity and timing of acute and chronic graft-vs-host disease in patients treated with this regimen
OUTLINE This is a pilot study
Preparative regimen Patients receive fludarabine IV over 30 minutes on days -7 to -3 busulfan IV over 2 hours 4 times daily on days -7 and -4 etoposide IV over 4 hours on day -3 and anti-thymocyte globulin IV over 6 hours on days -2 and -1
Donor umbilical cord blood transplantation UCBT Patients undergo donor UCBT on day 0 Beginning on day 7 patients receive sargramostim GM-CSF IV or subcutaneously once daily until blood counts recover
Graft-vs-host disease prophylaxis Patients receive tacrolimus IV continuously over 24 hours or orally twice daily beginning on day -2 and continuing until day 180 followed by a taper Patients also receive oral prednisone twice daily on days 13-50 and then once daily on days 50-60 followed by a rapid taper
After completion of study treatment patients are followed periodically for approximately 2 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
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 |
|---|---|---|---|
| UCSF-2207 | None | None | None |
| UCSF-02253 | None | None | None |
| UCSF-H24045-21269-04 | None | None | None |