Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005601
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of Cisplatinum Cytosine Arabinoside Dexamethasone DHAP With Rituxan in Patients With Relapsed CD20 B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-12
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 Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine response rate to cisplatin cytarabine and dexamethasone DHAP plus rituximab in patients with relapsed CD20 B-cell non-Hodgkins lymphoma
Determine the percentage of patients able to proceed to transplant after two courses of this treatment regimen
Determine the duration of response and overall survival of the patients not proceeding to transplant after two courses of this treatment regimen
OUTLINE Patients receive rituximab IV on days 1 8 15 and 22 for the first course only Patients receive dexamethasone orally or IV on days 1-4 cisplatin IV continuously for 24 hours on day 1 cytarabine IV over 3 hours every 12 hours for 2 doses on day 2 and sargramostim GM-CSF subcutaneously on days 3-12 or until blood counts recover Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 17-50 patients will be accrued for this study within 11 months
Determine response rate to cisplatin cytarabine and dexamethasone DHAP plus rituximab in patients with relapsed CD20 B-cell non-Hodgkins lymphoma
Determine the percentage of patients able to proceed to transplant after two courses of this treatment regimen
Determine the duration of response and overall survival of the patients not proceeding to transplant after two courses of this treatment regimen
OUTLINE Patients receive rituximab IV on days 1 8 15 and 22 for the first course only Patients receive dexamethasone orally or IV on days 1-4 cisplatin IV continuously for 24 hours on day 1 cytarabine IV over 3 hours every 12 hours for 2 doses on day 2 and sargramostim GM-CSF subcutaneously on days 3-12 or until blood counts recover Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 17-50 patients will be accrued for this study within 11 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 |
|---|---|---|---|
| CDR0000067714 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02326 | REGISTRY | None | None |