Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016887
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2001-06-06
Brief Title:
Chemotherapy Followed by Radiation Therapy and Peripheral Stem Cell Transplant Compared With Chemotherapy Plus Interferon Alfa in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
Sponsor:
German Low Grade Lymphoma Study Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Mantle Cell Lymphomas at Advanced Stages Prospective Randomized Comparison of Myeloablative Radiochemotherapy Followed by Blood Stem Cell Transplantation Versus Maintenance With Interferon Alpha in First Remission After Initial Cytoreductive Chemotherapy With an Anthracycline Containing Combination
Status:
UNKNOWN
Status Verified Date:
2003-08
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 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill cancer cells Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Interferon alfa may interfere with the growth of cancer cells It is not yet known whether giving more than one drug combination chemotherapy with radiation therapy and peripheral stem cell transplant is more effective than chemotherapy followed by interferon alfa in treating mantle cell lymphoma
PURPOSE This randomized phase III trial compares how well chemotherapy followed by radiation therapy chemotherapy and peripheral stem cell transplant works compared to chemotherapy plus interferon alfa in treating patients who have stage III or stage IV mantle cell lymphoma
PURPOSE This randomized phase III trial compares how well chemotherapy followed by radiation therapy chemotherapy and peripheral stem cell transplant works compared to chemotherapy plus interferon alfa in treating patients who have stage III or stage IV mantle cell lymphoma
Detailed Description:
OBJECTIVES
Compare the disease-free survival of patients with previously untreated advanced mantle cell lymphoma treated with intensified chemotherapy followed by myeloablative radiochemotherapy and peripheral blood stem cell transplantation PBSCT vs standard therapy and interferon alfa maintenance
Compare the overall survival of patients treated with early vs late myeloablative radiochemotherapy and PBSCT
Compare disease-free survival and overall survival of patients treated with this regimen vs historic controls of similar cases
OUTLINE This is a randomized multicenter study Patients are stratified according to risk factors ECOG performance status greater than 1 LDH serum level above normal andor extranodal lymphoma involvement and participating center Patients are randomized to 1 of 2 treatment arms
Induction All patients receive 4 courses of cytoreductive chemotherapy comprising an anthracycline-containing combination Patients not achieving complete remission after 4 courses receive 2 additional courses of induction chemotherapy Patients without at least a partial response after 6 courses discontinue treatment those with at least a partial response proceed to arm I or II
Arm I
Consolidation Patients achieving complete or partial remission after 4-6 courses of induction therapy begin intensified chemotherapy within 6 weeks Patients receive oral dexamethasone daily on days 1-10 carmustine IV on day 2 melphalan IV on day 3 etoposide IV daily and cytarabine IV twice a day on days 4-7 Patients also receive filgrastim G-CSF beginning on day 11 and continuing until peripheral blood stem cells PBSC are harvested
Within 4-6 weeks after PBSC harvest patients undergo myeloablative radiochemotherapy comprising radiotherapy on days -6 to -4 and cyclophosphamide IV on days -3 to -2 Patients then undergo PBSC transplantation on day 0
Arm II
Consolidation Patients receive 2 additional courses of induction chemotherapy as consolidation for a total of 8 chemotherapy courses
Maintenance Within 4 weeks after arm II consolidation patients receive interferon alfa subcutaneously SC 3 days a week in the absence of unacceptable toxicity or disease progression or relapse Patients who experience first relapse or progression during maintenance therapy may receive intensified chemotherapy as in arm I
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 210 patients will be accrued for this study within 5 years
Compare the disease-free survival of patients with previously untreated advanced mantle cell lymphoma treated with intensified chemotherapy followed by myeloablative radiochemotherapy and peripheral blood stem cell transplantation PBSCT vs standard therapy and interferon alfa maintenance
Compare the overall survival of patients treated with early vs late myeloablative radiochemotherapy and PBSCT
Compare disease-free survival and overall survival of patients treated with this regimen vs historic controls of similar cases
OUTLINE This is a randomized multicenter study Patients are stratified according to risk factors ECOG performance status greater than 1 LDH serum level above normal andor extranodal lymphoma involvement and participating center Patients are randomized to 1 of 2 treatment arms
Induction All patients receive 4 courses of cytoreductive chemotherapy comprising an anthracycline-containing combination Patients not achieving complete remission after 4 courses receive 2 additional courses of induction chemotherapy Patients without at least a partial response after 6 courses discontinue treatment those with at least a partial response proceed to arm I or II
Arm I
Consolidation Patients achieving complete or partial remission after 4-6 courses of induction therapy begin intensified chemotherapy within 6 weeks Patients receive oral dexamethasone daily on days 1-10 carmustine IV on day 2 melphalan IV on day 3 etoposide IV daily and cytarabine IV twice a day on days 4-7 Patients also receive filgrastim G-CSF beginning on day 11 and continuing until peripheral blood stem cells PBSC are harvested
Within 4-6 weeks after PBSC harvest patients undergo myeloablative radiochemotherapy comprising radiotherapy on days -6 to -4 and cyclophosphamide IV on days -3 to -2 Patients then undergo PBSC transplantation on day 0
Arm II
Consolidation Patients receive 2 additional courses of induction chemotherapy as consolidation for a total of 8 chemotherapy courses
Maintenance Within 4 weeks after arm II consolidation patients receive interferon alfa subcutaneously SC 3 days a week in the absence of unacceptable toxicity or disease progression or relapse Patients who experience first relapse or progression during maintenance therapy may receive intensified chemotherapy as in arm I
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 210 patients 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 |
|---|---|---|---|
| GISL-INTERGROUP-20995 | None | None | None |
| GER-LGLSG-INTERGROUP-20995 | None | None | None |
| EORTC-20995 | None | None | None |
| GELA-INTERGROUP-20995 | None | None | None |