Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216164
Status:
TERMINATED
Last Update Posted:
2011-05-02
First Post:
2005-09-12
Brief Title:
Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor:
Hoosier Cancer Research Network
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Hoosier Oncology Group LYM03-64
Status:
TERMINATED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to lack of response at the first efficacy analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic actions of several chemotherapy agents by enhancing sensitivity of tumor cells to chemotherapy-induced apoptosis Gemcitabine a nucleoside analog that is used in several other malignancies has shown very promising activity in patients with refractory Hodgkins disease and low-grade NHL The combination of rituximab and gemcitabine may have synergistic cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved response rates and demonstrable clinical benefit
This trial will investigate the efficacy the combination of rituximab and gemcitabine in treating patients with relapsed or refractory DLBCL
This trial will investigate the efficacy the combination of rituximab and gemcitabine in treating patients with relapsed or refractory DLBCL
Detailed Description:
OUTLINE This is a multi-center study
Rituximab 375 mgm2 day 1 of 21 day cycle
Gemcitabine 1000 mgm2 days 1 and 8 of 21 day cycle
Subgroup 1 Relapsed after responding to first line chemotherapy who are not candidates for salvage high-dose chemotherapy
Subgroup 2 Failure to achieve a complete response or relapsed after responding to salvage chemotherapy any number of salvage regimens allowed who are not candidates for high-dose chemotherapy
Subgroup 3 Refractory to first line chemotherapy andor 1 one salvage chemotherapy regimen
Subgroup 4 Progression after high-dose chemotherapy Patients with progressive disease within 3 months of high-dose chemotherapy are not allowed
Performance Status ECOG performance status 0 1 2
Life expectancy Not specified
Hematopoietic
ANC 1000mm3
Platelets 100000mm3
Hepatic
Total bilirubin 20 x ULN
ALT and AST 3 x ULN unless lymphoma involves the liver on CT scan then AST and ALT can be 5 x ULN
Renal
Serum creatinine 20 mgdl except for patients on dialysis
Cardiovascular
Not specified
Pulmonary
Not specified
Rituximab 375 mgm2 day 1 of 21 day cycle
Gemcitabine 1000 mgm2 days 1 and 8 of 21 day cycle
Subgroup 1 Relapsed after responding to first line chemotherapy who are not candidates for salvage high-dose chemotherapy
Subgroup 2 Failure to achieve a complete response or relapsed after responding to salvage chemotherapy any number of salvage regimens allowed who are not candidates for high-dose chemotherapy
Subgroup 3 Refractory to first line chemotherapy andor 1 one salvage chemotherapy regimen
Subgroup 4 Progression after high-dose chemotherapy Patients with progressive disease within 3 months of high-dose chemotherapy are not allowed
Performance Status ECOG performance status 0 1 2
Life expectancy Not specified
Hematopoietic
ANC 1000mm3
Platelets 100000mm3
Hepatic
Total bilirubin 20 x ULN
ALT and AST 3 x ULN unless lymphoma involves the liver on CT scan then AST and ALT can be 5 x ULN
Renal
Serum creatinine 20 mgdl except for patients on dialysis
Cardiovascular
Not specified
Pulmonary
Not specified
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