Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025636
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed Hodgkins Lymphoma
Sponsor:
German Hodgkins Lymphoma Study Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Trial Of BEAM Plus PBSCT Versus Single Agent High-Dose Therapy Followed By BEAM Plus PBSCT In Patients With Relapsed Hodgkins Disease
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkins lymphoma
PURPOSE This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkins lymphoma
PURPOSE This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the efficacy of induction chemotherapy followed by combination chemotherapy and autologous peripheral blood stem cell transplantation with or without high-dose sequential chemotherapy in terms of freedom from treatment failure in patients with relapsed Hodgkins lymphoma
Compare the toxicity of these regimens in these patients
Compare the complete remissionunconfirmed complete remission rate at 3 months relapse-free survival and overall survival of patients treated with these regimens
Compare the frequency of severe toxic effects and secondary neoplasia in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center type of relapse early first relapse remission duration 3-12 months vs late first relapse remission duration more than 12 months vs second relapse without prior high-dose chemotherapy salvage remission duration after salvage at least 3 months disease status at relapse stage I or II vs stage III or IV age 18 to 49 vs 50 to 60 and response after 2 courses of study induction chemotherapy complete remission vs partial remission vs no change
All patients receive induction chemotherapy comprising dexamethasone IV over 30 minutes on days 1-4 and 15-18 cisplatin IV continuously over 24 hours on days 1 and 15 cytarabine IV over 3 hours every 12 hours on days 2 and 16 and filgrastim G-CSF subcutaneously SC once daily on days 5-12 and days 19-26 Patients with complete remission CR unconfirmed CR partial remission or no change are randomized to one of two treatment arms
Arm I Patients receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 37 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 37-40 Patients also receive G-CSF SC twice daily beginning on day 41 and continuing until blood counts recover Autologous peripheral blood stem cells PBSCs are reinfused on day 42
Arm II Patients receive high-dose cyclophosphamide IV over 8 hours on day 37 high-dose methotrexate IV over 6 hours and high-dose vincristine IV on day 51 and high-dose etoposide IV over 8 hours on days 58-61 Patients then receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 80 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 80-83 Patients also receive G-CSF SC once on days 38 and 62 and twice daily beginning on day 84 and continuing until blood counts recover Autologous PBSCs are reinfused on day 85
Patients with residual lymphoma at 100 days after completion of BEAM chemotherapy may receive radiotherapy
Patients are followed at 100 days after PBSC transplantation every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 220 patients 110 per treatment arm will be accrued for this study within 5 years
Compare the efficacy of induction chemotherapy followed by combination chemotherapy and autologous peripheral blood stem cell transplantation with or without high-dose sequential chemotherapy in terms of freedom from treatment failure in patients with relapsed Hodgkins lymphoma
Compare the toxicity of these regimens in these patients
Compare the complete remissionunconfirmed complete remission rate at 3 months relapse-free survival and overall survival of patients treated with these regimens
Compare the frequency of severe toxic effects and secondary neoplasia in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center type of relapse early first relapse remission duration 3-12 months vs late first relapse remission duration more than 12 months vs second relapse without prior high-dose chemotherapy salvage remission duration after salvage at least 3 months disease status at relapse stage I or II vs stage III or IV age 18 to 49 vs 50 to 60 and response after 2 courses of study induction chemotherapy complete remission vs partial remission vs no change
All patients receive induction chemotherapy comprising dexamethasone IV over 30 minutes on days 1-4 and 15-18 cisplatin IV continuously over 24 hours on days 1 and 15 cytarabine IV over 3 hours every 12 hours on days 2 and 16 and filgrastim G-CSF subcutaneously SC once daily on days 5-12 and days 19-26 Patients with complete remission CR unconfirmed CR partial remission or no change are randomized to one of two treatment arms
Arm I Patients receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 37 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 37-40 Patients also receive G-CSF SC twice daily beginning on day 41 and continuing until blood counts recover Autologous peripheral blood stem cells PBSCs are reinfused on day 42
Arm II Patients receive high-dose cyclophosphamide IV over 8 hours on day 37 high-dose methotrexate IV over 6 hours and high-dose vincristine IV on day 51 and high-dose etoposide IV over 8 hours on days 58-61 Patients then receive BEAM chemotherapy comprising carmustine IV over 30 minutes and melphalan IV over 30 minutes on day 80 and etoposide IV over 30 minutes every 12 hours and cytarabine IV over 30 minutes every 12 hours on days 80-83 Patients also receive G-CSF SC once on days 38 and 62 and twice daily beginning on day 84 and continuing until blood counts recover Autologous PBSCs are reinfused on day 85
Patients with residual lymphoma at 100 days after completion of BEAM chemotherapy may receive radiotherapy
Patients are followed at 100 days after PBSC transplantation every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 220 patients 110 per treatment arm will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-20011 | None | None | None |
| GHSG-HD-R2 | None | None | None |
| EBMT-GHSG-HD-R2 | None | None | None |