Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003152
Status:
TERMINATED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Interferon Alfa Alone or With Radiation Therapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkins Lymphoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation Followed by Interferon-Alpha Maintenance Treatment Versus Interferon-Alpha Maintenance Treatment Alone After a Chemotherapy-Induced Remission in Patients With Stages III or IV Follicular Non-Hodgkins Lymphoma A Prospective Randomized Phase III Clinical Trial
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 Interferon alfa may interfere with the growth of cancer cells Radiation therapy uses high-energy x-rays to damage cancer cells Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by interferon alfa alone or combination chemotherapy plus radiation therapy and peripheral stem cell transplantation in treating patients who have previously untreated stage III or stage IV follicular non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by interferon alfa alone or combination chemotherapy plus radiation therapy and peripheral stem cell transplantation in treating patients who have previously untreated stage III or stage IV follicular non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Compare the progression free and overall survival toxicity and mortality of marrow ablative chemoradiotherapy in addition to peripheral blood stem cell transplantation and interferon alfa maintenance therapy versus interferon alfa maintenance therapy alone in patients with follicular non-Hodgkins lymphoma
OUTLINE This is a randomized study All patients receive 8 courses of cyclophosphamidevincristineprednisone CVP chemotherapy Cyclophosphamide and vincristine IV are given on day 1 along with oral prednisone on days 1-5 Courses are repeated every 3 weeks Patients are randomized to receive one of two treatments 4 weeks after completion of CVP chemotherapy if a partial or complete response is achieved and there are less than 15 monoclonal B-lymphocytes in the bone marrow Patients randomized to arm I receive interferon alfa subcutaneously 3 times per week for a maximum of 3 years Patients randomized to arm II receive cyclophosphamide IV followed by subcutaneous filgrastim granulocyte colony-stimulating factor G-CSF Leukapheresis begins after leukocyte platelet and CD34 levels recover and lasts 3-4 hours on 2-3 consecutive days If an insufficient number of stem cells are collected from the peripheral blood bone marrow harvesting is performed After stem cell collection a conditioning regimen consisting of cyclophosphamide IV on days -4 and -3 and total body irradiation on day -1 is administered Stem cells are infused on day 0 If granulocyte and platelet counts recover within 8 weeks patients receive interferon alfa maintenance therapy as in arm I Patients are followed every 4 months until death
PROJECTED ACCRUAL A total of 469 patients will be accrued for this study within 5 years
OUTLINE This is a randomized study All patients receive 8 courses of cyclophosphamidevincristineprednisone CVP chemotherapy Cyclophosphamide and vincristine IV are given on day 1 along with oral prednisone on days 1-5 Courses are repeated every 3 weeks Patients are randomized to receive one of two treatments 4 weeks after completion of CVP chemotherapy if a partial or complete response is achieved and there are less than 15 monoclonal B-lymphocytes in the bone marrow Patients randomized to arm I receive interferon alfa subcutaneously 3 times per week for a maximum of 3 years Patients randomized to arm II receive cyclophosphamide IV followed by subcutaneous filgrastim granulocyte colony-stimulating factor G-CSF Leukapheresis begins after leukocyte platelet and CD34 levels recover and lasts 3-4 hours on 2-3 consecutive days If an insufficient number of stem cells are collected from the peripheral blood bone marrow harvesting is performed After stem cell collection a conditioning regimen consisting of cyclophosphamide IV on days -4 and -3 and total body irradiation on day -1 is administered Stem cells are infused on day 0 If granulocyte and platelet counts recover within 8 weeks patients receive interferon alfa maintenance therapy as in arm I Patients are followed every 4 months until death
PROJECTED ACCRUAL A total of 469 patients will be accrued for this study within 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 |
|---|---|---|---|
| EORTC-20963 | None | None | None |
| BNLI-EORTC-20963 | None | None | None |
| HOVON-35 | None | None | None |