Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002567
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
1999-11-01
Brief Title:
High-Dose Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia in Remission
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
PHASE II STUDY EVALUATING AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION FOR ACUTE LEUKEMIAS
Status:
COMPLETED
Status Verified Date:
2013-06
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 Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of high-dose radiation therapy and etoposide followed by peripheral stem cell transplantation in treating patients with acute leukemia
PURPOSE Phase II trial to study the effectiveness of high-dose radiation therapy and etoposide followed by peripheral stem cell transplantation in treating patients with acute leukemia
Detailed Description:
OBJECTIVES I Evaluate the efficacy of myeloablative total-body irradiation and etoposide followed by autologous peripheral blood stem cell PBSC transplantation in prolonging the disease-free survival of patients with acute leukemia II Investigate the ability of growth factor-primed PBSC to provide hematopoietic reconstitution following myeloablative therapy
OUTLINE Patients are treated on Regimen A then Regimen B Regimen A Stem Cell Mobilization Granulocyte Colony Stimulating Factor Amgen G-CSF NSC-614629 Regimen B Radiotherapy and Myeloablative Chemotherapy with Hematopoietic Rescue Total-Body Irradiation TBI high-energy electrons used for lung boost and Etoposide VP-16 NSC-141540 with Peripheral Blood Stem Cells PBSC G-CSF
PROJECTED ACCRUAL Up to 45 patients will be studied over approximately 3 years
OUTLINE Patients are treated on Regimen A then Regimen B Regimen A Stem Cell Mobilization Granulocyte Colony Stimulating Factor Amgen G-CSF NSC-614629 Regimen B Radiotherapy and Myeloablative Chemotherapy with Hematopoietic Rescue Total-Body Irradiation TBI high-energy electrons used for lung boost and Etoposide VP-16 NSC-141540 with Peripheral Blood Stem Cells PBSC G-CSF
PROJECTED ACCRUAL Up to 45 patients will be studied over approximately 3 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 |
|---|---|---|---|
| CDR0000063595 | REGISTRY | None | None |
| NCI-H94-0460 | Registry Identifier | PDQ Physician Data Query | None |