Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005998
Status:
WITHDRAWN
Last Update Posted:
2017-11-29
First Post:
2000-07-05
Brief Title:
Peripheral Stem Cell Transplantation With Specially Treated Stem Cells in Treating Patients With Non-Hodgkins Lymphoma or Hodgkins Disease
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Autologous Transplantation for Non-Hodgkins Lymphoma and Hodgkins Disease Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Mobilization Using Hematopoietic Cytokines Plus Chemotherapy
Status:
WITHDRAWN
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn because study never enrolled patients
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 Combining chemotherapy and radiation therapy with peripheral stem cell transplantation using specially treated stem cells may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation using specially treated stem cells in treating patients who have non-Hodgkins lymphoma or Hodgkins disease
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation using specially treated stem cells in treating patients who have non-Hodgkins lymphoma or Hodgkins disease
Detailed Description:
OBJECTIVES
Determine whether priming with hematopoietic cytokines and chemotherapy increases the yield of hematopoietic progenitors in peripheral blood stem cells PBSC in patients with non-Hodgkins lymphoma or Hodgkins disease undergoing autologous PBSC transplantation
Determine whether in vitro studies can predict the transduction efficiency of early and late engrafting hematopoietic stem cells in this patient population undergoing this treatment
Determine whether in vitro transduction of a graft product stable long term transduction of marrow cells in these patients after autologous transplantation
OUTLINE Patients receive filgrastim G-CSF subcutaneously SC twice daily on days 1-7 Peripheral blood stem cells PBSC are collected on days 5-7 Patients receive cyclophosphamide IV over 2 hours mitoxantrone IV and cytarabine IV every 12 hours for 2 doses on day 10 and dexamethasone every 12 hours for 4 doses on days 10 and 11 Patients receive G-CSF SC for the next 10-20 days Additional PBSC are collected on days 25-28 or 29 Beginning 7 days before PBSC transplantation patients receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation TBI twice daily on days -4 to -1 Patients unable to tolerate TBI receive cyclophosphamide IV over 2 hours on days -6 to -3 carmustine IV over 1 hour on days -6 and etoposide IV over 1 hour every 12 hours on days -6 to -4 Retrovirally transduced PBSC are reinfused on day 0 followed by another course of G-CSF SC until hematopoietic recovery
Patients are followed at 1 3 6 9 12 18 and 24 months and then annually thereafter
PROJECTED ACCRUAL A total of 15-20 patients will be accrued for this study within 12-15 months
Determine whether priming with hematopoietic cytokines and chemotherapy increases the yield of hematopoietic progenitors in peripheral blood stem cells PBSC in patients with non-Hodgkins lymphoma or Hodgkins disease undergoing autologous PBSC transplantation
Determine whether in vitro studies can predict the transduction efficiency of early and late engrafting hematopoietic stem cells in this patient population undergoing this treatment
Determine whether in vitro transduction of a graft product stable long term transduction of marrow cells in these patients after autologous transplantation
OUTLINE Patients receive filgrastim G-CSF subcutaneously SC twice daily on days 1-7 Peripheral blood stem cells PBSC are collected on days 5-7 Patients receive cyclophosphamide IV over 2 hours mitoxantrone IV and cytarabine IV every 12 hours for 2 doses on day 10 and dexamethasone every 12 hours for 4 doses on days 10 and 11 Patients receive G-CSF SC for the next 10-20 days Additional PBSC are collected on days 25-28 or 29 Beginning 7 days before PBSC transplantation patients receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation TBI twice daily on days -4 to -1 Patients unable to tolerate TBI receive cyclophosphamide IV over 2 hours on days -6 to -3 carmustine IV over 1 hour on days -6 and etoposide IV over 1 hour every 12 hours on days -6 to -4 Retrovirally transduced PBSC are reinfused on day 0 followed by another course of G-CSF SC until hematopoietic recovery
Patients are followed at 1 3 6 9 12 18 and 24 months and then annually thereafter
PROJECTED ACCRUAL A total of 15-20 patients will be accrued for this study within 12-15 months
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-G00-1807 | Other Identifier | Blood and Marrow Transplantation Program | None |
| MT1999-19 | OTHER | None | None |