Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003335
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
1999-11-01
Brief Title:
Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2012-03
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 Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells
PURPOSE This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer
PURPOSE This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer
Detailed Description:
OBJECTIVES
Determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood UCB transplantation
Determine the incidence of graft-versus-host-disease in this setting
Describe the incidence of recurrent disease in these patients post UCB transplant
Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients
Determine specifically whether larger recipients can be durably engrafted with unrelated UCB and determine whether nucleated cell or progenitor cell content of the graft is predictive of hematological engraftment
OUTLINE Patients may undergo a back-up peripheral blood stem cell collection prior to treatment
Patients receive 9 fractions of total body irradiation TBI on days -9 to -5 followed by melphalan IV for three days on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV for three days on days -3 to -1 On day 0 patients receive umbilical cord blood infusion If TBI is not tolerated busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5 Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months
Patients are followed at least monthly for 1 year then every 6 months for the second year and then annually thereafter
PROJECTED ACCRUAL There will be a maximum of 48 patients accrued into this study over 4 years
Determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood UCB transplantation
Determine the incidence of graft-versus-host-disease in this setting
Describe the incidence of recurrent disease in these patients post UCB transplant
Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients
Determine specifically whether larger recipients can be durably engrafted with unrelated UCB and determine whether nucleated cell or progenitor cell content of the graft is predictive of hematological engraftment
OUTLINE Patients may undergo a back-up peripheral blood stem cell collection prior to treatment
Patients receive 9 fractions of total body irradiation TBI on days -9 to -5 followed by melphalan IV for three days on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV for three days on days -3 to -1 On day 0 patients receive umbilical cord blood infusion If TBI is not tolerated busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5 Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months
Patients are followed at least monthly for 1 year then every 6 months for the second year and then annually thereafter
PROJECTED ACCRUAL There will be a maximum of 48 patients accrued into this study over 4 years
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 |
|---|---|---|---|
| CWRU4Y97 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| NCI-G98-1429 | None | None | None |