Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003397
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
1999-11-01
Brief Title:
Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Autologous Stem Cell Transplantation for Poor Prognosis Relapsed or Refractory Intermediate-High Grade B-Cell Lymphoma Using Gemcitabine Plus High Dose BCNU and Melphalan Followed by Anti-CD20 Moab IDEC C2B8 Rituximab Rituxan and Consolidative Chemotherapy
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 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 Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Evaluate the 1 and 2 year event free survival of patients with poor prognosis relapsed or refractory intermediate or high grade B-cell non-Hodgkins lymphoma who receive high dose carmustine and melphalan plus gemcitabine followed by rituximab IDEC-C2B8 monoclonal antibody anti-CD20 monoclonal antibody plus sargramostim and consolidation chemotherapy with alternating dexamethasonecyclophosphamide etoposidecisplatin plus gemcitabine and paclitaxelcisplatin and compare these figures to a historical control population II Evaluate the ability of posttransplant rituximab therapy in combination with sargramostim GM-CSF to control and further treat residual lymphoma remaining after high dose therapy in these patients III Evaluate quality of life parameters and assess the risk of secondary malignancies following this treatment regimen in these patients
OUTLINE Patients receive high dose gemcitabine IV over 100 minutes on day -5 and again approximately 6 hours after carmustine IV over 2 hours on day -2 On day -1 patients receive melphalan IV over 20 minutes followed 24 hours later day 0 with peripheral blood stem cells transplantation Patients then receive sargramostim GM-CSF subcutaneously beginning on day 4 until granulocyte count is greater than 1000mm3 for 2 consecutive days At weeks 5-8 posttransplant patients receive rituximab IDEC-C2B8 monoclonal antibody anti-CD20 monoclonal antibody IV over 3-4 hours weekly Prior to rituximab treatment at week 4 posttransplant patients receive sargramostim GM-CSF subcutaneously 3 times a week continuing through rituximab therapy At approximately 3 and 9 months posttransplant patients receive dexamethasone orally every day for days 1-4 and cyclophosphamide etoposide and cisplatin by continuous infusion for 4 days days 1-4 and gemcitabine IV over 100 minutes on days 1 and 5 At approximately 6 and 12 months posttransplant patients receive paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3 Patients are followed at least every 6 weeks to 3 months until death
PROJECTED ACCRUAL An estimated 25 patients per year will be accrued into this study
OUTLINE Patients receive high dose gemcitabine IV over 100 minutes on day -5 and again approximately 6 hours after carmustine IV over 2 hours on day -2 On day -1 patients receive melphalan IV over 20 minutes followed 24 hours later day 0 with peripheral blood stem cells transplantation Patients then receive sargramostim GM-CSF subcutaneously beginning on day 4 until granulocyte count is greater than 1000mm3 for 2 consecutive days At weeks 5-8 posttransplant patients receive rituximab IDEC-C2B8 monoclonal antibody anti-CD20 monoclonal antibody IV over 3-4 hours weekly Prior to rituximab treatment at week 4 posttransplant patients receive sargramostim GM-CSF subcutaneously 3 times a week continuing through rituximab therapy At approximately 3 and 9 months posttransplant patients receive dexamethasone orally every day for days 1-4 and cyclophosphamide etoposide and cisplatin by continuous infusion for 4 days days 1-4 and gemcitabine IV over 100 minutes on days 1 and 5 At approximately 6 and 12 months posttransplant patients receive paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3 Patients are followed at least every 6 weeks to 3 months until death
PROJECTED ACCRUAL An estimated 25 patients per year will be accrued into 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-V98-1432 | None | None | None |
| MSGCC-9740 | None | None | None |