Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005631
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-05-02
Brief Title:
Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Large Cell Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Cytoreduction and Stem Cell Mobilization With Rituximab and ICE for Patients With Refractory or Relapsed CD20 B-Cell IGL Eligible for ASCT The RICE Protocol
Status:
COMPLETED
Status Verified Date:
2013-06
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 combination chemotherapy with monoclonal antibody therapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of rituximab and combination chemotherapy in treating patients who have relapsed or refractory large cell lymphoma
PURPOSE Phase II trial to study the effectiveness of rituximab and combination chemotherapy in treating patients who have relapsed or refractory large cell lymphoma
Detailed Description:
OBJECTIVES I Determine the complete response rate in patients with relapsed or refractory CD20-positive diffuse large cell immunoblastic or anaplastic large cell lymphoma treated with cytoreduction and mobilization with rituximab ifosfamide carboplatin and etoposide RICE II Assess the ability of this regimen to deplete the stem cell harvest of B-cells and tumor cells in these patients III Assess the efficacy of this regimen to mobilize peripheral blood progenitor cells in these patients IV Assess the safety and toxicity of this regimen in these patients
OUTLINE Cytoreduction and mobilization Patients receive ifosfamide IV over 24 hours and carboplatin IV on day 4 and etoposide IV over 1 hour on days 3-5 Chemotherapy repeats every 2 weeks for 3 courses Patients receive rituximab IV on day -2 before initiation of chemotherapy and on day 1 of each course of chemotherapy Patients receive filgrastim G-CSF subcutaneously SC daily on days 7-14 of each course of chemotherapy Patients with complete or partial response after completion of course 3 continue to receive G-CSF SC daily until peripheral blood stem cells PBSC are harvested When blood counts recover PBSC are harvested and selected for CD34 cells If sufficient numbers of CD34 cells are not obtained patients undergo bone marrow harvest
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 2 years
OUTLINE Cytoreduction and mobilization Patients receive ifosfamide IV over 24 hours and carboplatin IV on day 4 and etoposide IV over 1 hour on days 3-5 Chemotherapy repeats every 2 weeks for 3 courses Patients receive rituximab IV on day -2 before initiation of chemotherapy and on day 1 of each course of chemotherapy Patients receive filgrastim G-CSF subcutaneously SC daily on days 7-14 of each course of chemotherapy Patients with complete or partial response after completion of course 3 continue to receive G-CSF SC daily until peripheral blood stem cells PBSC are harvested When blood counts recover PBSC are harvested and selected for CD34 cells If sufficient numbers of CD34 cells are not obtained patients undergo bone marrow harvest
PROJECTED ACCRUAL A total of 36 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-G00-1774 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067785 | REGISTRY | None | None |