Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003270
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
1999-11-01
Brief Title:
Chemotherapy Radiation Therapy and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Cord Blood Transplantation for Hematologic Malignancies and Bone Marrow Failure Syndromes
Status:
COMPLETED
Status Verified Date:
2019-11
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy radiation therapy and umbilical cord blood transplantation in treating patients with hematologic cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy radiation therapy and umbilical cord blood transplantation in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES I Determine the safety efficacy and toxicity of using cord blood as a source for stem cell transplantation in patients with hematologic malignancies
OUTLINE Patients undergo autologous bone marrow harvesting or peripheral stem cell collection prior to transplant regimen unless the patient has acute leukemia in relapse aplastic anemia or myelodysplastic syndrome Arm I Patients eligible to undergo total body irradiation TBI first receive cyclophosphamide IV over 2 hours on days -5 and -4 then undergo TBI twice a day on days -3 to -1 Patients also receive antithymocyte globulin ATG IV over 10 hours on days -3 to -1 Cord blood is infused on day 0 Arm II Patients not eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses Cyclophosphamide ATG and cord blood are then administered as in arm I All patients receive cyclosporine on days -2 to 180 methylprednisolone on days 5-180 and filgrastim G-CSF from day 1 Patients are followed weekly until day 180 and then monthly for 2 years
PROJECTED ACCRUAL A total of 20 patients 10 patients per arm will be accrued for this study within 4 years
OUTLINE Patients undergo autologous bone marrow harvesting or peripheral stem cell collection prior to transplant regimen unless the patient has acute leukemia in relapse aplastic anemia or myelodysplastic syndrome Arm I Patients eligible to undergo total body irradiation TBI first receive cyclophosphamide IV over 2 hours on days -5 and -4 then undergo TBI twice a day on days -3 to -1 Patients also receive antithymocyte globulin ATG IV over 10 hours on days -3 to -1 Cord blood is infused on day 0 Arm II Patients not eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses Cyclophosphamide ATG and cord blood are then administered as in arm I All patients receive cyclosporine on days -2 to 180 methylprednisolone on days 5-180 and filgrastim G-CSF from day 1 Patients are followed weekly until day 180 and then monthly for 2 years
PROJECTED ACCRUAL A total of 20 patients 10 patients per arm will be accrued for this study within 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 |
|---|---|---|---|
| DS 97-26 | None | None | None |