Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005985
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2000-07-05
Brief Title:
Filgrastim and Chemotherapy Followed by Peripheral Stem Cell Transplant in Treating Patients With Hodgkins Lymphoma or Non-Hodgkins Lymphoma
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Primed Peripheral Blood Stem Cell Autologous Transplantation for Lymphoma and Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2017-11
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 transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE This phase II trial is studying how well giving filgrastim together with chemotherapy and peripheral stem cell transplant works in treating patients with Hodgkins lymphoma or non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving filgrastim together with chemotherapy and peripheral stem cell transplant works in treating patients with Hodgkins lymphoma or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Assess the clinical outcomes survival and morbidity of transplantation in patients with Hodgkins lymphoma or non-Hodgkins lymphoma when treated with filgrastim G-CSF followed by high dose chemotherapy plus G-CSF followed by autologous peripheral blood stem cell PBSC transplantation
Determine whether sufficient PBSC can be collected for use in autologous transplantation in these patients when mobilized with hematopoietic growth factor alone compared to chemotherapy plus growth factor
Determine whether these primed PBSC support prompt lymphoid and myeloid hematopoietic recovery after transplantation in these patients
Compare the numbers of committed progenitor cells andor primitive pluripotential hematopoietic stem cells with these two priming techniques
Compare the numbers of tumor cells in cryopreserved PBSC following these priming techniques
Evaluate response and extended relapse free survival in conjunction with rapid hematopoietic reconstitution and limited transplant associated morbidity and mortality in these patients when treated with these regimens
OUTLINE In the first priming phase patients receive filgrastim G-CSF subcutaneously SQ daily on days 1-7 and peripheral blood stem cells are collected on days 6-8
At least 48 hours after the last dose of G-CSF and after the third leukapheresis patients receive the second priming which consists of cyclophosphamide IV over 2 hours on day 1 and cytarabine IV over 1 hour every 12 hours for a total of 2 doses on day 1 Patients also receive mitoxantrone IV over 1 hour daily and dexamethasone IV every 12 hours for a total of 4 doses on days 1-2 Patients receive G-CSF SQ daily beginning on day 4 and continuing until the completion of leukapheresis PBSC are collected on 3 consecutive days after blood counts recover
In the transplant phase patients with non-Hodgkins lymphoma who have not exceeded pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice daily on days -4 through -1 Autologous PBSC are reinfused on day 0 Patients receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until blood counts recover
Patients with Hodgkins lymphoma or patients with non-Hodgkins lymphoma who have exceeded pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours daily on days -6 through -3 carmustine IV over 1 hour on day -6 and etoposide IV over 4 hours every 12 hours for a total of 6 doses on days -6 through -4 Autologous PBSC are reinfused on day 0 Patients also receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until blood counts recover
All patients receive radiotherapy for any residual nodal masses measuring at least 2 cm 5 days a week beginning on day 28
Patients are followed at day 100 then every 3 months for 1 year then every 6 months for 2 years and then annually thereafter
This was changed to a treatment guideline study
Assess the clinical outcomes survival and morbidity of transplantation in patients with Hodgkins lymphoma or non-Hodgkins lymphoma when treated with filgrastim G-CSF followed by high dose chemotherapy plus G-CSF followed by autologous peripheral blood stem cell PBSC transplantation
Determine whether sufficient PBSC can be collected for use in autologous transplantation in these patients when mobilized with hematopoietic growth factor alone compared to chemotherapy plus growth factor
Determine whether these primed PBSC support prompt lymphoid and myeloid hematopoietic recovery after transplantation in these patients
Compare the numbers of committed progenitor cells andor primitive pluripotential hematopoietic stem cells with these two priming techniques
Compare the numbers of tumor cells in cryopreserved PBSC following these priming techniques
Evaluate response and extended relapse free survival in conjunction with rapid hematopoietic reconstitution and limited transplant associated morbidity and mortality in these patients when treated with these regimens
OUTLINE In the first priming phase patients receive filgrastim G-CSF subcutaneously SQ daily on days 1-7 and peripheral blood stem cells are collected on days 6-8
At least 48 hours after the last dose of G-CSF and after the third leukapheresis patients receive the second priming which consists of cyclophosphamide IV over 2 hours on day 1 and cytarabine IV over 1 hour every 12 hours for a total of 2 doses on day 1 Patients also receive mitoxantrone IV over 1 hour daily and dexamethasone IV every 12 hours for a total of 4 doses on days 1-2 Patients receive G-CSF SQ daily beginning on day 4 and continuing until the completion of leukapheresis PBSC are collected on 3 consecutive days after blood counts recover
In the transplant phase patients with non-Hodgkins lymphoma who have not exceeded pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice daily on days -4 through -1 Autologous PBSC are reinfused on day 0 Patients receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until blood counts recover
Patients with Hodgkins lymphoma or patients with non-Hodgkins lymphoma who have exceeded pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours daily on days -6 through -3 carmustine IV over 1 hour on day -6 and etoposide IV over 4 hours every 12 hours for a total of 6 doses on days -6 through -4 Autologous PBSC are reinfused on day 0 Patients also receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until blood counts recover
All patients receive radiotherapy for any residual nodal masses measuring at least 2 cm 5 days a week beginning on day 28
Patients are followed at day 100 then every 3 months for 1 year then every 6 months for 2 years and then annually thereafter
This was changed to a treatment guideline 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 |
|---|---|---|---|
| UMN-MT-9527 | None | None | None |
| UMN-MT-1995-27 | None | None | None |