Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003815
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Aggressive Non-Hodgkins Lymphoma
Sponsor:
Scotland and Newcastle Lymphoma Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Study of High Dose ChemotherapyRadiotherapy and Autologous Bone Marrow Transplantation in Patients With High Grade Malignant Non-Hodgkins Lymphoma Kiel Classification According to Prognostic Groups
Status:
UNKNOWN
Status Verified Date:
2001-07
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 Radiation therapy uses high-energy x-rays to damage cancer cells Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Randomized phase III trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow transplantation in treating patients who have aggressive non-Hodgkins lymphoma
PURPOSE Randomized phase III trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow transplantation in treating patients who have aggressive non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Assess the rate of remission in patients with aggressive non-Hodgkins lymphoma treated with high-dose chemotherapy and radiotherapy plus autologous bone marrow transplantation
Determine the efficacy and toxic effects of this regimen in these patients
OUTLINE This is a randomized placebo-controlled multicenter study Patients are stratified according to risk group good vs intermediate vs poor
Patients undergo harvest of autologous bone marrow stem cells after priming chemotherapy and before transplantation
Patients receive induction chemotherapy comprising the CHOP or VAPEC-B regimen The CHOP regimen consists of vincristine VCR IV cyclophosphamide CTX IV and doxorubicin DOX IV on day 1 and oral prednisolone PRDL on days 1-5 Treatment repeats every 3 weeks for six courses The VAPEC-B regimen consists of DOX IV on days 1 15 29 43 57 and 71 CTX IV on days 1 29 and 57 VCR IV on days 8 22 36 50 and 64 bleomycin IV on days 8 36 64 oral etoposide VP-16 on days 15-19 43-47 and 71-75 and oral PRDL daily for 13 weeks
Patients then may undergo radiotherapy for 2-3 weeks to areas of original bulk or residual disease
Good-risk group Patients are randomized to one of two treatment arms
Arm I Patients receive no further treatment
Arm II Patients receive melphalan L-PAM before or after total body irradiation TBI which is delivered in 3 fractions over 24 hours After completion of radiotherapy patients undergo autologous bone marrow transplantation AuBMT
Intermediate- or poor-risk group Patients are randomized one of three treatment arms
Arm III Patients receive L-PAM IV on day -2 and AuBMT on day 0
Arm IV Patients receive treatment as in arm II
Arm V Patients receive carmustine IV on day -6 VP-16 IV once daily and cytarabine IV twice daily on days -5 to -2 and L-PAM IV on day -1 Radiotherapy to bulk disease begins after completion of chemotherapy Patients undergo AuBMT on day 0
Patients are followed monthly for 3 months every 2 months for 1 year every 4 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL Not specified
Assess the rate of remission in patients with aggressive non-Hodgkins lymphoma treated with high-dose chemotherapy and radiotherapy plus autologous bone marrow transplantation
Determine the efficacy and toxic effects of this regimen in these patients
OUTLINE This is a randomized placebo-controlled multicenter study Patients are stratified according to risk group good vs intermediate vs poor
Patients undergo harvest of autologous bone marrow stem cells after priming chemotherapy and before transplantation
Patients receive induction chemotherapy comprising the CHOP or VAPEC-B regimen The CHOP regimen consists of vincristine VCR IV cyclophosphamide CTX IV and doxorubicin DOX IV on day 1 and oral prednisolone PRDL on days 1-5 Treatment repeats every 3 weeks for six courses The VAPEC-B regimen consists of DOX IV on days 1 15 29 43 57 and 71 CTX IV on days 1 29 and 57 VCR IV on days 8 22 36 50 and 64 bleomycin IV on days 8 36 64 oral etoposide VP-16 on days 15-19 43-47 and 71-75 and oral PRDL daily for 13 weeks
Patients then may undergo radiotherapy for 2-3 weeks to areas of original bulk or residual disease
Good-risk group Patients are randomized to one of two treatment arms
Arm I Patients receive no further treatment
Arm II Patients receive melphalan L-PAM before or after total body irradiation TBI which is delivered in 3 fractions over 24 hours After completion of radiotherapy patients undergo autologous bone marrow transplantation AuBMT
Intermediate- or poor-risk group Patients are randomized one of three treatment arms
Arm III Patients receive L-PAM IV on day -2 and AuBMT on day 0
Arm IV Patients receive treatment as in arm II
Arm V Patients receive carmustine IV on day -6 VP-16 IV once daily and cytarabine IV twice daily on days -5 to -2 and L-PAM IV on day -1 Radiotherapy to bulk disease begins after completion of chemotherapy Patients undergo AuBMT on day 0
Patients are followed monthly for 3 months every 2 months for 1 year every 4 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| EU-98032 | None | None | None |
| SNLG-NHL-Va | None | None | None |