Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028665
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2002-01-04
Brief Title:
Cyclophosphamide Wor WOut Rituximab and Peripheral Stem Cell Transplantation in Patients With Recurrent Non-Hodgkins Lymphoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Randomized Phase II Trial of B-Lymphocyte Purging of Autologous Peripheral Blood Progenitor Cells in Patients With B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2010-06
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells 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 It is not yet known if combining rituximab with cyclophosphamide is more effective than cyclophosphamide alone in stimulating peripheral stem cells for transplantation
PURPOSE This randomized phase II trial is studying how well giving cyclophosphamide with or without rituximab followed by chemotherapy and peripheral stem cell transplantation works in treating patients with recurrent non-Hodgkins lymphoma
PURPOSE This randomized phase II trial is studying how well giving cyclophosphamide with or without rituximab followed by chemotherapy and peripheral stem cell transplantation works in treating patients with recurrent non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the effects of mobilization therapy with or without rituximab on hematopoietic stem cells B and T lymphocytes and natural killer cells in patients with advanced or recurrent B-cell non-Hodgkins lymphoma
Compare the effects of B-lymphocyte purging using concurrent rituximab and mobilization therapy vs a CD34 cell enrichment device on hematopoietic stem cells B and T lymphocytes and natural killer cells in the peripheral blood stem cell PBSC infusates
Compare the effect of these purging regimens on tumor cell content of PBSC infusates
Compare the effects of these regimens on myeloid and lymphoid engraftment after high-dose chemotherapy and autologous PBSC infusion in these patients
Compare post-transplantation infection complications in patients treated with these regimens
Compare the response and relapse-free survival of patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive mobilization therapy comprising rituximab IV over 2-5 hours on days 1 8 and 15 and cyclophosphamide IV over 3-6 hours on day 16 Beginning 36-48 hours after the completion of cyclophosphamide patients receive filgrastim G-CSF subcutaneously SC daily until blood counts recover Patients then undergo peripheral blood stem cell PBSC collection
After completion of PBSC collection patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3 and etoposide IV and cisplatin IV for 3 days during days -7 to -3 Patients may undergo involved-field radiotherapy to active or previously bulky more than 5 cm tumors daily for 7-10 days
Patients receive unmanipulated PBSCs on day 0 Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment
Arm II Patients receive mobilization therapy comprising cyclophosphamide and G-CSF and high-dose chemotherapy comprising carmustine etoposide and cisplatin as in arm I Patients may also undergo involved-field radiotherapy as in arm I Patients receive CD34 cell-enriched PBSC on day 0 followed by G-CSF as in arm I
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study within 2 years
Compare the effects of mobilization therapy with or without rituximab on hematopoietic stem cells B and T lymphocytes and natural killer cells in patients with advanced or recurrent B-cell non-Hodgkins lymphoma
Compare the effects of B-lymphocyte purging using concurrent rituximab and mobilization therapy vs a CD34 cell enrichment device on hematopoietic stem cells B and T lymphocytes and natural killer cells in the peripheral blood stem cell PBSC infusates
Compare the effect of these purging regimens on tumor cell content of PBSC infusates
Compare the effects of these regimens on myeloid and lymphoid engraftment after high-dose chemotherapy and autologous PBSC infusion in these patients
Compare post-transplantation infection complications in patients treated with these regimens
Compare the response and relapse-free survival of patients treated with these regimens
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive mobilization therapy comprising rituximab IV over 2-5 hours on days 1 8 and 15 and cyclophosphamide IV over 3-6 hours on day 16 Beginning 36-48 hours after the completion of cyclophosphamide patients receive filgrastim G-CSF subcutaneously SC daily until blood counts recover Patients then undergo peripheral blood stem cell PBSC collection
After completion of PBSC collection patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3 and etoposide IV and cisplatin IV for 3 days during days -7 to -3 Patients may undergo involved-field radiotherapy to active or previously bulky more than 5 cm tumors daily for 7-10 days
Patients receive unmanipulated PBSCs on day 0 Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment
Arm II Patients receive mobilization therapy comprising cyclophosphamide and G-CSF and high-dose chemotherapy comprising carmustine etoposide and cisplatin as in arm I Patients may also undergo involved-field radiotherapy as in arm I Patients receive CD34 cell-enriched PBSC on day 0 followed by G-CSF as in arm I
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 71 patients will be accrued for this study within 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-G01-2040 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU1499 | OTHER | None | None |
| CWRU-030040 | None | None | None |