Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244985
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2005-10-25
Brief Title:
Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase III Pilot Study of the Safety and Efficacy of Rituxan Chimeric Anti-CD20 Antibody in Combination With Doxil Liposomal Doxorubicin Chemotherapy in Patients With Relapsing or Refractory Indolent or Aggressive B-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-07
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 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 Drugs used in chemotherapy such as liposomal doxorubicin work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving rituximab together with liposomal doxorubicin may kill more cancer cells
PURPOSE This phase III trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkins lymphoma
PURPOSE This phase III trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety including qualitative and quantitative toxic effects and their duration and reversibility of rituximab and doxorubicin HCl liposome in patients with relapsed or refractory indolent or aggressive CD20-positive B-cell non-Hodgkins lymphoma
Secondary
Determine the efficacy including overall response rate and durability of objective response of this regimen in these patients
Correlate pretreatment functional phenotypic and genotypic characteristics of host immune effector cells with response in patients treated with this regimen
OUTLINE This is an open-label pilot study
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 4 years
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Primary
Determine the safety including qualitative and quantitative toxic effects and their duration and reversibility of rituximab and doxorubicin HCl liposome in patients with relapsed or refractory indolent or aggressive CD20-positive B-cell non-Hodgkins lymphoma
Secondary
Determine the efficacy including overall response rate and durability of objective response of this regimen in these patients
Correlate pretreatment functional phenotypic and genotypic characteristics of host immune effector cells with response in patients treated with this regimen
OUTLINE This is an open-label pilot study
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 4 years
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
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 |
|---|---|---|---|
| RPC 02-04 | OTHER | Roswell Park Cancer Institute | None |