Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003396
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
1999-11-01
Brief Title:
Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Evaluation of Allogeneic Peripheral Blood Stem Cell Transplants From a Related Donor Without Graft-Versus-Host Prophylaxis in Patients With High Risk of Relapse
Status:
COMPLETED
Status Verified Date:
2019-10
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation from related donors to prevent graft-versus-host disease in treating patients with hematologic cancer
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation from related donors to prevent graft-versus-host disease in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES I Evaluate the use of donor peripheral blood stem cells without graft-versus-host disease prophylaxis to maximize the probability of graft-versus-tumor effect in patients with hematologic malignancies refractory to standard chemotherapy and unlikely to be cured with high dose chemotherapy and radiotherapy
OUTLINE Prior to peripheral blood stem cell transplant patients undergo preparative cytoreduction Patients receive total body irradiation TBI beginning on day -5 Radiotherapy is administered in 9 doses over 3 days 3 doses per day for 3 days Male patients with acute lymphocytic leukemia receive an additional dose of radiation to the testicles Patients who are ineligible for TBI due to prior radiotherapy receive 2 doses of melphalan IV on day -3 All patients receive cyclophosphamide IV over 1 hour on days -2 and -1 Anti-thymocyte globulin is also administered IV over 6 hours on days -2 and -1 Approximately 24-36 hours after the last dose of cyclophosphamide peripheral blood stem cells obtained from the HLA matched related donor are infused into the patient Patients do not receive graft-versus-host disease prophylaxis after transplant however all other forms of supportive care are provided Patients are followed for 1 year
PROJECTED ACCRUAL A maximum of 42 patients will be accrued for this study
OUTLINE Prior to peripheral blood stem cell transplant patients undergo preparative cytoreduction Patients receive total body irradiation TBI beginning on day -5 Radiotherapy is administered in 9 doses over 3 days 3 doses per day for 3 days Male patients with acute lymphocytic leukemia receive an additional dose of radiation to the testicles Patients who are ineligible for TBI due to prior radiotherapy receive 2 doses of melphalan IV on day -3 All patients receive cyclophosphamide IV over 1 hour on days -2 and -1 Anti-thymocyte globulin is also administered IV over 6 hours on days -2 and -1 Approximately 24-36 hours after the last dose of cyclophosphamide peripheral blood stem cells obtained from the HLA matched related donor are infused into the patient Patients do not receive graft-versus-host disease prophylaxis after transplant however all other forms of supportive care are provided Patients are followed for 1 year
PROJECTED ACCRUAL A maximum of 42 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 |
|---|---|---|---|
| NCI-V98-1430 | None | None | None |
| MSGCC-9805 | None | None | None |