Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005946
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
2000-07-05
Brief Title:
Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Pilot Study of Combined Chemotherapy and Donor Lymphocyte Infusion for Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die White blood cells from donors may be able to prevent graft-versus-host disease in patients with hematologic cancer that has relapsed following donor peripheral stem cell transplantation
PURPOSE Phase I trial to study the effectiveness of chemotherapy plus donor white blood cell infusion in treating patients who have relapsed hematologic cancer following donor peripheral stem cell transplantation
PURPOSE Phase I trial to study the effectiveness of chemotherapy plus donor white blood cell infusion in treating patients who have relapsed hematologic cancer following donor peripheral stem cell transplantation
Detailed Description:
OBJECTIVES I Determine the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60 graft versus host disease in patients with hematologic malignancies relapsed after allogeneic stem cell transplantation
OUTLINE This is a dose de-escalation study Patients receive etoposide IV continuously on days 1-3 cyclophosphamide IV on day 8 donor lymphocyte infusion IV on day 10 and filgrastim G-CSF subcutaneously or IV beginning on day 10 and continuing until blood counts recover Cohorts of 3-6 patients receive six de-escalating levels of chemotherapy until the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60 graft versus host disease GVHD is determined The target dose level is defined as the level at which 2 of 6 patients develop GVHD and the next lower dose level has no more than 1 patient experiencing GVHD Patients are followed every 3 months for the first year every 6 months for the second year and yearly thereafter
PROJECTED ACCRUAL A total of 18-21 patients will be accrued over 2 years
OUTLINE This is a dose de-escalation study Patients receive etoposide IV continuously on days 1-3 cyclophosphamide IV on day 8 donor lymphocyte infusion IV on day 10 and filgrastim G-CSF subcutaneously or IV beginning on day 10 and continuing until blood counts recover Cohorts of 3-6 patients receive six de-escalating levels of chemotherapy until the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60 graft versus host disease GVHD is determined The target dose level is defined as the level at which 2 of 6 patients develop GVHD and the next lower dose level has no more than 1 patient experiencing GVHD Patients are followed every 3 months for the first year every 6 months for the second year and yearly thereafter
PROJECTED ACCRUAL A total of 18-21 patients will be accrued over 2 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 |
|---|---|---|---|
| NCI-V00-1588 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067863 | REGISTRY | None | None |