Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423826
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2016-02-29
First Post:
2007-01-16
Brief Title:
Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
A Pilot Study of Double Cord Blood Stem Cell Transplantation in Patients With Hematologic Malignancies
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2016-02
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 low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells It also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining cancer or abnormal cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving tacrolimus and mycophenolate mofetil before the transplant may stop this from happening
PURPOSE This clinical trial is studying how well umbilical cord blood stem cell transplant works in treating patients with hematologic cancer or other disease
PURPOSE This clinical trial is studying how well umbilical cord blood stem cell transplant works in treating patients with hematologic cancer or other disease
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of double umbilical cord blood stem cell transplantation using a conditioning regimen comprising lower doses of busulfan and fludarabine phosphate and low-dose total body irradiation in terms of stem cell engraftment at 60 days post transplantation in patients with hematologic cancer or other diseases
Determine the merits of conducting a larger comparative study of this regimen
Secondary
Determine mortality within 100 days of transplantation in these patients
OUTLINE This is a pilot study
Reduced-intensity conditioning regimen Patients receive busulfan IV over 3 hours on days -9 to -8 and fludarabine phosphate IV on days -7 to -3 Patients then undergo low-dose total body irradiation on day 0
Graft-versus-host disease prophylaxis Patients receive tacrolimus IV twice daily and mycophenolate orally or IV three times daily beginning on day -3
CNS prophylaxis andor treatment Patients with a history of CNS involvement receive prophylactic cytarabine Ara-C intrathecally IT prior to transplant Patients also undergo lumbar puncture LP to test for active CNS disease Patients with cerebrospinal fluid positive for leukemia receive Ara-C IT every 2-3 days until a repeat LP shows no remaining leukemic cells Three days after the last LP and after one final dose of Ara-C patients begin the conditioning regimen
Double umbilical cord blood UCB donor stem cell transplantation SCT Patients undergo double UCB donor SCT on day 0
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the efficacy of double umbilical cord blood stem cell transplantation using a conditioning regimen comprising lower doses of busulfan and fludarabine phosphate and low-dose total body irradiation in terms of stem cell engraftment at 60 days post transplantation in patients with hematologic cancer or other diseases
Determine the merits of conducting a larger comparative study of this regimen
Secondary
Determine mortality within 100 days of transplantation in these patients
OUTLINE This is a pilot study
Reduced-intensity conditioning regimen Patients receive busulfan IV over 3 hours on days -9 to -8 and fludarabine phosphate IV on days -7 to -3 Patients then undergo low-dose total body irradiation on day 0
Graft-versus-host disease prophylaxis Patients receive tacrolimus IV twice daily and mycophenolate orally or IV three times daily beginning on day -3
CNS prophylaxis andor treatment Patients with a history of CNS involvement receive prophylactic cytarabine Ara-C intrathecally IT prior to transplant Patients also undergo lumbar puncture LP to test for active CNS disease Patients with cerebrospinal fluid positive for leukemia receive Ara-C IT every 2-3 days until a repeat LP shows no remaining leukemic cells Three days after the last LP and after one final dose of Ara-C patients begin the conditioning regimen
Double umbilical cord blood UCB donor stem cell transplantation SCT Patients undergo double UCB donor SCT on day 0
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| WSU-112506MP2F | OTHER | Wayne State University Institutional Review Board | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-2006-059 | OTHER | None | None |