Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295932
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2006-02-23
Brief Title:
Bortezomib Rituximab Cyclophosphamide and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of the Novel Proteasome Inhibitor Bortezomib in Combination With Rituximab Cyclophosphamide and Prednisone in Patients With RelapsedRefractory Indolent B-Cell Lymphoproliferative Disorders and Mantle Cell Lymphoma MCL
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
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 Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as cyclophosphamide and prednisone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving bortezomib together with cyclophosphamide prednisone and rituximab may be an effective treatment for non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying the side effects and best dose of bortezomib when given together with cyclophosphamide prednisone and rituximab and to see how well it works in treating patients with relapsed or refractory indolent B-cell non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying the side effects and best dose of bortezomib when given together with cyclophosphamide prednisone and rituximab and to see how well it works in treating patients with relapsed or refractory indolent B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of bortezomib when given in combination with rituximab cyclophosphamide and prednisone R-CP in patients with relapsed or refractory indolent B-cell lymphoproliferative disorders or mantle cell lymphoma phase I
Determine the frequency and duration of complete and partial responses in patients treated with two different treatment regimes phase II
Secondary
Evaluate the progression-free survival event-free survival and overall survival of patients treated with this regimen phase II
Evaluate the toxicity profile of this regimen
OUTLINE This is a phase I dose-escalation study of bortezomib followed by a phase II randomized multicenter study Patients in phase II are stratified according to disease mantle cell lymphoma vs indolent B-cell lymphoproliferative disorder vs transformed lymphoma
Phase I Patients receive cyclophosphamide IV and rituximab IV on day 1 oral prednisone on days 2-6 and bortezomib IV on days 2 and 7 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cyclophosphamide IV and rituximab IV on day 1 oral prednisone on days 2-6 and bortezomib IV at the MTD determined in phase I on days 2 5 9 and 12 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive cyclophosphamide IV and rituximab IV on day 1 oral prednisone on days 2-6 and bortezomib IV at the MTD determined in phase I on days 2 and 8 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 1 month every 4 months for 2 years and then every 6 months thereafter
Primary
Determine the maximum tolerated dose of bortezomib when given in combination with rituximab cyclophosphamide and prednisone R-CP in patients with relapsed or refractory indolent B-cell lymphoproliferative disorders or mantle cell lymphoma phase I
Determine the frequency and duration of complete and partial responses in patients treated with two different treatment regimes phase II
Secondary
Evaluate the progression-free survival event-free survival and overall survival of patients treated with this regimen phase II
Evaluate the toxicity profile of this regimen
OUTLINE This is a phase I dose-escalation study of bortezomib followed by a phase II randomized multicenter study Patients in phase II are stratified according to disease mantle cell lymphoma vs indolent B-cell lymphoproliferative disorder vs transformed lymphoma
Phase I Patients receive cyclophosphamide IV and rituximab IV on day 1 oral prednisone on days 2-6 and bortezomib IV on days 2 and 7 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cyclophosphamide IV and rituximab IV on day 1 oral prednisone on days 2-6 and bortezomib IV at the MTD determined in phase I on days 2 5 9 and 12 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive cyclophosphamide IV and rituximab IV on day 1 oral prednisone on days 2-6 and bortezomib IV at the MTD determined in phase I on days 2 and 8 Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 1 month every 4 months for 2 years and then every 6 months thereafter
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 |
|---|---|---|---|
| MSKCC-05103 | None | None | None |