Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450801
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2007-03-20
Brief Title:
R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Phase II Study of Rituximab in Combination With Methotrexate Doxorubicin Cyclophosphamide Leucovorin Vincristine Ifosfamide Etoposide Cytarabine and Mesna MACLOIVAM in Patients With Previously Untreated Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-10
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 To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma
PURPOSE This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the progression-free survival of patients with previously untreated mantle cell lymphoma treated rituximab in combination with methotrexate doxorubicin cyclophosphamide leucovorin vincristine ifosfamide etoposide cytarabine and mesna MACLOIVAM followed by thalidomide
Secondary
Determine the overall survival of patients treated with this regimen
Determine the response rate in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE During cycle 1 patients will receive rituximab intravenous IV granisetron IV decadron IV doxorubicin IV bolus vincristine intravenous pyelogram IVP on day 1 cyclophosphamide IV on day 1-5 vincristine IVP on day 8 methotrexate IV methotrexate by continuous infusion then leucovorin IV until methotrexate level is below 001 nanomolar nM on day 10 Patients will receive filgrastim G-CSF subcutaneously SC once daily beginning on day 13 and continuing until blood counts recover
When absolute neutrophil count ANC reaches1500mm3 patients will start cycle 2 Patients will receive rituximab IV on day 1 cytarabine IV on day 1 and 2 ifosfamide IV mesna IV etoposide IV on day 1-5 and G-CSF SC daily beginning on day 7 and continuing until ANC is greater than 1000 cellsmm3
Approximately 2-3 weeks later patients receive another course of therapy as aboveAfter cycle 4 patients in complete remission will take oral thalidomide until progression of disease After completion of study treatment patients are followed monthly for 3 months every 3 months for 2 years every 6 months for 3-5 years and then annually thereafter or at study termination
PROJECTED ACCRUAL A total of 22 patients will be accrued for this study
Primary
Determine the progression-free survival of patients with previously untreated mantle cell lymphoma treated rituximab in combination with methotrexate doxorubicin cyclophosphamide leucovorin vincristine ifosfamide etoposide cytarabine and mesna MACLOIVAM followed by thalidomide
Secondary
Determine the overall survival of patients treated with this regimen
Determine the response rate in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE During cycle 1 patients will receive rituximab intravenous IV granisetron IV decadron IV doxorubicin IV bolus vincristine intravenous pyelogram IVP on day 1 cyclophosphamide IV on day 1-5 vincristine IVP on day 8 methotrexate IV methotrexate by continuous infusion then leucovorin IV until methotrexate level is below 001 nanomolar nM on day 10 Patients will receive filgrastim G-CSF subcutaneously SC once daily beginning on day 13 and continuing until blood counts recover
When absolute neutrophil count ANC reaches1500mm3 patients will start cycle 2 Patients will receive rituximab IV on day 1 cytarabine IV on day 1 and 2 ifosfamide IV mesna IV etoposide IV on day 1-5 and G-CSF SC daily beginning on day 7 and continuing until ANC is greater than 1000 cellsmm3
Approximately 2-3 weeks later patients receive another course of therapy as aboveAfter cycle 4 patients in complete remission will take oral thalidomide until progression of disease After completion of study treatment patients are followed monthly for 3 months every 3 months for 2 years every 6 months for 3-5 years and then annually thereafter or at study termination
PROJECTED ACCRUAL A total of 22 patients will be accrued for 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 |
|---|---|---|---|
| WIRB-20051242 | OTHER | Western Institutional Review Board | None |
| SCCC-2003027 | OTHER | None | None |