Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004114
Status:
WITHDRAWN
Last Update Posted:
2020-07-31
First Post:
1999-12-10
Brief Title:
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Hematologic Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies A Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never opened
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells
PURPOSE Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced hematologic cancer
PURPOSE Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced hematologic cancer
Detailed Description:
OBJECTIVES I Determine the feasibility of allogeneic engraftment after unrelated matched allogeneic peripheral blood stem cell transplantation preceded by a nonmyeloablative fludarabine based conditioning regimen in patients with advanced hematologic malignancies II Determine the toxicities of this regimen especially graft versus host disease in these patients
OUTLINE Patients receive fludarabine IV over 30-60 minutes on days -7 to -4 cyclophosphamide IV over 30 minutes on days -7 to -5 and cytarabine IV over 2 hours on days -4 and -3 Allogeneic peripheral blood stem cells are infused on day 0 Filgrastim G-CSF is administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until blood counts recover Patients are followed weekly until day 60 and then monthly for 10 months
PROJECTED ACCRUAL A total of 6 patients will be accrued for this study
OUTLINE Patients receive fludarabine IV over 30-60 minutes on days -7 to -4 cyclophosphamide IV over 30 minutes on days -7 to -5 and cytarabine IV over 2 hours on days -4 and -3 Allogeneic peripheral blood stem cells are infused on day 0 Filgrastim G-CSF is administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until blood counts recover Patients are followed weekly until day 60 and then monthly for 10 months
PROJECTED ACCRUAL A total of 6 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-G99-1603 | None | None | None |
| UCLA-9902026 | None | None | None |