Ignite Creation Date:
2024-05-05 @ 11:19 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01307592
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2011-03-01
Brief Title:
Gemcitabine Hydrochloride Rituximab Oxaliplatin and Lenalidomide in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma
Sponsor:
Auxilio Mutuo Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Study of GC Gemcitabine-Rituximab-Oxaliplatin Combination Given Every 14 Days With Maintenance Lenalidomide for the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkins Lymphoma
Status:
UNKNOWN
Status Verified Date:
2011-02
Last Known Status:
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 such as gemcitabine hydrochloride oxaliplatin and 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 cell 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 Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer Giving rituximab and chemotherapy together with lenalidomide may kill more cancer cells
PURPOSE This phase II trial is studying how well giving rituximab gemcitabine hydrochloride and oxaliplatin together with lenalidomide works in treating patients with relapsed or refractory aggressive non-Hodgkin lymphoma
PURPOSE This phase II trial is studying how well giving rituximab gemcitabine hydrochloride and oxaliplatin together with lenalidomide works in treating patients with relapsed or refractory aggressive non-Hodgkin lymphoma
Detailed Description:
OBJECTIVES
Primary
To determine the rate of conversion to complete response CR after switching to lenalidomide in patients with relapsed or refractory aggressive non-Hodgkin lymphoma whose maximum response to gemcitabine hydrochloride rituximab and oxaliplatin is a partial response PR
Secondary
To determine the overall survival of these patients treated with this regimen
To determine the progression-free survival of patients with CR and PR
To determine the treatment-related toxicity of this regimen combination in these patients
OUTLINE This is a multicenter study
Rituximab gemcitabine hydrochloride and oxaliplatin Patients with B-cell lymphoma receive rituximab IV on day 1 all patients receive gemcitabine hydrochloride IV over 30 minutes and oxaliplatin IV over 2 hours on day 1 or day 2 Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
NOTE Patients with T-cell lymphoma proceed to chemotherapy on day 1 without receiving rituximab patients with B-cell lymphoma receive chemotherapy on day 2
Patients are reevaluated after 4 courses of therapy Patients who achieve a complete response CR receive 2 more courses of therapy and then proceed to bone marrow transplantation BMT those that do not receive a BMT receive maintenance lenalidomide for 2 years Patients who achieve a partial response PR and who are not candidate for autologous stem cell transplantation ACT are treated with lenalidomide Once patients with PR achieve a CR or CR with lenalidomide treatment they proceed to maintenance lenalidomide for 2 years unless they become candidates for ACT Patients with stable disease or progressive disease after 4 courses of therapy are treated with lenalidomide unless they become eligible for ACT
NOTE Patients in whom a delay of 4 months would occur for ACT are treated with lenalidomide until 3 weeks prior to ACT
NOTE Once eligible patients proceed to ACT as soon as feasible
Maintenance lenalidomide Patients receive oral lenalidomide once daily on days 1-21 Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and periodically for toxicity analysis
After completion of study treatment patients are followed up at 28 days and then every 3 months thereafter
Primary
To determine the rate of conversion to complete response CR after switching to lenalidomide in patients with relapsed or refractory aggressive non-Hodgkin lymphoma whose maximum response to gemcitabine hydrochloride rituximab and oxaliplatin is a partial response PR
Secondary
To determine the overall survival of these patients treated with this regimen
To determine the progression-free survival of patients with CR and PR
To determine the treatment-related toxicity of this regimen combination in these patients
OUTLINE This is a multicenter study
Rituximab gemcitabine hydrochloride and oxaliplatin Patients with B-cell lymphoma receive rituximab IV on day 1 all patients receive gemcitabine hydrochloride IV over 30 minutes and oxaliplatin IV over 2 hours on day 1 or day 2 Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
NOTE Patients with T-cell lymphoma proceed to chemotherapy on day 1 without receiving rituximab patients with B-cell lymphoma receive chemotherapy on day 2
Patients are reevaluated after 4 courses of therapy Patients who achieve a complete response CR receive 2 more courses of therapy and then proceed to bone marrow transplantation BMT those that do not receive a BMT receive maintenance lenalidomide for 2 years Patients who achieve a partial response PR and who are not candidate for autologous stem cell transplantation ACT are treated with lenalidomide Once patients with PR achieve a CR or CR with lenalidomide treatment they proceed to maintenance lenalidomide for 2 years unless they become candidates for ACT Patients with stable disease or progressive disease after 4 courses of therapy are treated with lenalidomide unless they become eligible for ACT
NOTE Patients in whom a delay of 4 months would occur for ACT are treated with lenalidomide until 3 weeks prior to ACT
NOTE Once eligible patients proceed to ACT as soon as feasible
Maintenance lenalidomide Patients receive oral lenalidomide once daily on days 1-21 Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and periodically for toxicity analysis
After completion of study treatment patients are followed up at 28 days and then every 3 months thereafter
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 |
|---|---|---|---|
| CAM-09-01 | None | None | None |
| CELGENE-RV-NHL-PI-0452 | None | None | None |