Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003311
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II CCOP Trial of High Dose MethotrexateARA-C and HCVAD for Newly Diagnosed Nodular and Diffuse Mantle Cell Lymphoma and Their Blastic Variants
Status:
COMPLETED
Status Verified Date:
2018-11
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 more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of different regimens of combination chemotherapy in treating patients with newly diagnosed mantle cell lymphoma
PURPOSE Phase II trial to study the effectiveness of different regimens of combination chemotherapy in treating patients with newly diagnosed mantle cell lymphoma
Detailed Description:
OBJECTIVES
Evaluate the complete response rate and duration of response in patients with newly diagnosed diffuse or nodular mantle cell lymphoma or their blastic variant treated with high-dose methotrexate and cytarabine and high-dose cyclophosphamide dexamethasone doxorubicin and vincristine HCVAD
OUTLINE This is a multicenter study Patients may receive either regimen A or both regimen A and regimen B depending upon response
Regimen A Patients receive methotrexate IV over 24 hours on day 1 Cytarabine is administered IV over 2 hours every 12 hours on days 2 and 3 Filgrastim G-CSF is administered subcutaneously SC daily beginning on day 4 and continuing until blood counts recover Treatment repeats every 21 days for up to 8 courses
Regimen B Patients receive cyclophosphamide IV over 3 hours every 12 hours on days 1-3 Doxorubicin is administered IV over 24 hours on days 4 and 5 Vincristine is administered IV over 30 minutes on days 4 and 11 Dexamethasone is administered orally or IV on days 1-4 and 11-14 G-CSF is administered SC beginning on day 6 and continuing until blood counts recover Treatment repeats every 21 days for up to 7 courses
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within 4 years
Evaluate the complete response rate and duration of response in patients with newly diagnosed diffuse or nodular mantle cell lymphoma or their blastic variant treated with high-dose methotrexate and cytarabine and high-dose cyclophosphamide dexamethasone doxorubicin and vincristine HCVAD
OUTLINE This is a multicenter study Patients may receive either regimen A or both regimen A and regimen B depending upon response
Regimen A Patients receive methotrexate IV over 24 hours on day 1 Cytarabine is administered IV over 2 hours every 12 hours on days 2 and 3 Filgrastim G-CSF is administered subcutaneously SC daily beginning on day 4 and continuing until blood counts recover Treatment repeats every 21 days for up to 8 courses
Regimen B Patients receive cyclophosphamide IV over 3 hours every 12 hours on days 1-3 Doxorubicin is administered IV over 24 hours on days 4 and 5 Vincristine is administered IV over 30 minutes on days 4 and 11 Dexamethasone is administered orally or IV on days 1-4 and 11-14 G-CSF is administered SC beginning on day 6 and continuing until blood counts recover Treatment repeats every 21 days for up to 7 courses
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| DM97-200 | OTHER | UT MD Anderson Cancer Center | None |
| MDA-DM-97200 | None | None | None |
| NCI-T97-0101 | None | None | None |