Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003215
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkins Lymphoma
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Standard Chemotherapy CHOP Regimen Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkins Lymphomas and Poor Prognostic Factors A Randomized Phase III Study MISTRAL
Status:
COMPLETED
Status Verified Date:
2012-05
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 tumor cells from dividing so they stop growing or die Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the efficacy of sequential high-dose chemotherapy and autologous peripheral blood stem cell transplantation with standard chemotherapy cyclophosphamide doxorubicin vincristine and prednisone in patients with newly diagnosed aggressive non-Hodgkins lymphoma and poor prognostic factors
Compare the toxic effects of these 2 regimens in these patients
Compare the response rates and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive standard chemotherapy comprising cyclophosphamide doxorubicin vincristine and prednisone CHOP Patients receive cyclophosphamide IV over 30 minutes doxorubicin IV and vincristine IV on day 1 Patients receive oral prednisone daily on days 1-5 Treatment repeats every 21 days for 6-8 courses Patients with bulky disease at diagnosis or residual disease after chemotherapy receive radiotherapy 30-60 days after initiation of the last course of CHOP
Arm II Patients receive 5 regimens of chemotherapy administered in sequence
Regimen A Patients receive CHOP as in Arm I
Regimen B Three weeks after starting regimen A patients receive high-dose cyclophosphamide IV over 24 hours on day 1 Patients without initial bone marrow involvement receive filgrastim G-CSF subcutaneously SC daily beginning on day 3 and continuing until autologous peripheral blood stem cells PBSC are harvested PBSC are harvested on days 13-15 or when blood counts recover Patients with initial bone marrow involvement do not undergo harvest of PBSC at this time but receive G-CSF SC daily
Regimen C Two to three weeks after high-dose cyclophosphamide patients receive vincristine IV and high-dose methotrexate IV over 6 hours on day 2 Patients receive leucovorin calcium IV every 6 hours on days 3-5 beginning 24 hours after initiation of the methotrexate infusion
Regimen D Within 1-2 weeks after the administration of methotrexate in regimen C patients receive methylprednisolone IV followed 6 hours later by high-dose etoposide IV over 10 hours on day 1 Patients receive methylprednisolone IV on day 2 Patients without initial bone marrow involvement receive G-CSF SC daily beginning on day 3 and continuing until blood counts recover Patients with initial bone marrow involvement receive G-CSF SC daily until autologous PBSC are harvested PBSC are harvested on days 10-14 or when blood counts recover
Regimen E Myeloablative therapy and autologous PBSC transplantation begin 16-40 days after the administration of etoposide Patients receive mitoxantrone IV over 1 hour every 2 hours for 3 doses on day 2 and melphalan IV over 30 minutes on day 5 PBSC are reinfused on day 6 beginning at least 24 hours after the administration of melphalan Patients receive G-CSF SC or by continuous infusion beginning on day 7
Patients with bulky disease at diagnosis or residual disease after chemotherapy receive radiotherapy 30-100 days after PBSC transplantation
Patients at high risk of developing CNS disease receive prophylactic intrathecal chemotherapy Patients may receive cytarabine methotrexate and hydrocortisone or methotrexate and hydrocortisone every 1-2 weeks for 6 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 400 patients will be accrued for this study within 4-5 years
Compare the efficacy of sequential high-dose chemotherapy and autologous peripheral blood stem cell transplantation with standard chemotherapy cyclophosphamide doxorubicin vincristine and prednisone in patients with newly diagnosed aggressive non-Hodgkins lymphoma and poor prognostic factors
Compare the toxic effects of these 2 regimens in these patients
Compare the response rates and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive standard chemotherapy comprising cyclophosphamide doxorubicin vincristine and prednisone CHOP Patients receive cyclophosphamide IV over 30 minutes doxorubicin IV and vincristine IV on day 1 Patients receive oral prednisone daily on days 1-5 Treatment repeats every 21 days for 6-8 courses Patients with bulky disease at diagnosis or residual disease after chemotherapy receive radiotherapy 30-60 days after initiation of the last course of CHOP
Arm II Patients receive 5 regimens of chemotherapy administered in sequence
Regimen A Patients receive CHOP as in Arm I
Regimen B Three weeks after starting regimen A patients receive high-dose cyclophosphamide IV over 24 hours on day 1 Patients without initial bone marrow involvement receive filgrastim G-CSF subcutaneously SC daily beginning on day 3 and continuing until autologous peripheral blood stem cells PBSC are harvested PBSC are harvested on days 13-15 or when blood counts recover Patients with initial bone marrow involvement do not undergo harvest of PBSC at this time but receive G-CSF SC daily
Regimen C Two to three weeks after high-dose cyclophosphamide patients receive vincristine IV and high-dose methotrexate IV over 6 hours on day 2 Patients receive leucovorin calcium IV every 6 hours on days 3-5 beginning 24 hours after initiation of the methotrexate infusion
Regimen D Within 1-2 weeks after the administration of methotrexate in regimen C patients receive methylprednisolone IV followed 6 hours later by high-dose etoposide IV over 10 hours on day 1 Patients receive methylprednisolone IV on day 2 Patients without initial bone marrow involvement receive G-CSF SC daily beginning on day 3 and continuing until blood counts recover Patients with initial bone marrow involvement receive G-CSF SC daily until autologous PBSC are harvested PBSC are harvested on days 10-14 or when blood counts recover
Regimen E Myeloablative therapy and autologous PBSC transplantation begin 16-40 days after the administration of etoposide Patients receive mitoxantrone IV over 1 hour every 2 hours for 3 doses on day 2 and melphalan IV over 30 minutes on day 5 PBSC are reinfused on day 6 beginning at least 24 hours after the administration of melphalan Patients receive G-CSF SC or by continuous infusion beginning on day 7
Patients with bulky disease at diagnosis or residual disease after chemotherapy receive radiotherapy 30-100 days after PBSC transplantation
Patients at high risk of developing CNS disease receive prophylactic intrathecal chemotherapy Patients may receive cytarabine methotrexate and hydrocortisone or methotrexate and hydrocortisone every 1-2 weeks for 6 courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 400 patients will be accrued for this study within 4-5 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 |
|---|---|---|---|
| EU-97037 | None | None | None |
| SWS-SAKK-3897 | None | None | None |