Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003578
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
High Dose Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Intermediate- or High-Grade Non-Hodgkins Lymphoma
Sponsor:
Lymphoma Trials Office
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Trial to Evaluate Early High Dose Therapy and Autologous Bone Marrow Transplantation as Part of Planned Initial Therapy for Poor Risk IntermediateHigh Grade NHL
Status:
UNKNOWN
Status Verified Date:
2007-05
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 Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells It is not yet known whether high dose chemotherapy plus bone marrow transplantation is more effective than high dose chemotherapy alone for intermediate- or high-grade non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of high dose chemotherapy with or without bone marrow transplantation in treating patients who have intermediate- or high-grade non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of high dose chemotherapy with or without bone marrow transplantation in treating patients who have intermediate- or high-grade non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Assess the value of early intensification with autologous bone marrow transplantation or stem cell support in patients with poor prognosis intermediate or high grade non-Hodgkins lymphoma
OUTLINE This is a randomized multicenter study Patients are stratified by age under 50 vs 50 and over bone marrow involvement yes vs no and country All patients receive cyclophosphamide doxorubicin and vincristine on day 1 and prednisone on days 1-5 Courses repeat every 21 days Patients receive a minimum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity Arm I Patients receive carmustine IV over 2 hours on day 1 in week 9 or 10 Etoposide and cytarabine IV are administered over 30 minutes on days 2-5 Melphalan IV is administered over 5 minutes on day 6 Patients receive cryopreserved bone marrow or peripheral blood stem cells on day 7 Arm II Patients continue conventional therapy Patients are followed at 8-9 weeks and 6 months
PROJECTED ACCRUAL This study will accrue 500 patients
OUTLINE This is a randomized multicenter study Patients are stratified by age under 50 vs 50 and over bone marrow involvement yes vs no and country All patients receive cyclophosphamide doxorubicin and vincristine on day 1 and prednisone on days 1-5 Courses repeat every 21 days Patients receive a minimum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity Arm I Patients receive carmustine IV over 2 hours on day 1 in week 9 or 10 Etoposide and cytarabine IV are administered over 30 minutes on days 2-5 Melphalan IV is administered over 5 minutes on day 6 Patients receive cryopreserved bone marrow or peripheral blood stem cells on day 7 Arm II Patients continue conventional therapy Patients are followed at 8-9 weeks and 6 months
PROJECTED ACCRUAL This study will accrue 500 patients
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-98039 | None | None | None |
| BNLI-LY02 | None | None | None |