Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Registration Number
- NCT00216164
- Lead Sponsor
- Hoosier Cancer Research Network
- 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 Hodgkin's 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.
- Detailed Description
OUTLINE: This is a multi-center study.
* Rituximab 375 mg/m2 day 1 of 21 day cycle
* Gemcitabine 1000 mg/m2 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 and/or 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 ≥ 1,000/mm3·
* Platelets ≥ 100,000/mm3
Hepatic:·
* Total bilirubin ≤ 2.0 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 ≤ 2.0 mg/dl (except for patients on dialysis)
Cardiovascular:·
* Not specified
Pulmonary:·
* Not specified
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- Biopsy-proven DLBCL which meet the criteria of any of the 4 subgroups
- Transformed DLBCL from a previous indolent NHL which meet the criteria of any of the 4 subgroups and have received at least one standard chemotherapy regimen for aggressive NHL or a biopsy upon progression of disease has been obtained to confirm the presence of DLBCL. The concomitant presence of a component of low grade lymphoma will NOT exclude participation
- Measurable disease per Standardized Response Criteria for Non-Hodgkin's Lymphoma
- Prior gemcitabine therapy is allowed.
- Negative pregnancy test
- No history of life-threatening reactions to rituximab.
- No history of gemcitabine intolerance; prior gemcitabine therapy is allowed.
- No history of malignancy in the last 5 years (basal cell carcinoma of the skin excluded).
- No central nervous system or cerebrospinal fluid involvement
- No other investigational drugs received within 30 days prior to being registered for protocol therapy.
- No active infections.
- No current breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Gemcitabine Rituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma 1 Rituximab Rituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Primary Outcome Measures
Name Time Method · Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL. 18 months
- Secondary Outcome Measures
Name Time Method · Evaluate toxicity, time to progression and overall survival. 18 months
Trial Locations
- Locations (9)
Providence Medical Group
🇺🇸Terre Haute, Indiana, United States
Elkhart Clinic
🇺🇸Elkhart, Indiana, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Quality Cancer Center (MCGOP)
🇺🇸Indianapolis, Indiana, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
Oncology Hematology Associates of SW Indiana
🇺🇸Evansville, Indiana, United States
Fort Wayne Oncology & Hematology, Inc
🇺🇸Fort Wayne, Indiana, United States
Center for Cancer Care, Inc., P.C.
🇺🇸New Albany, Indiana, United States
AP&S Clinic
🇺🇸Terre Haute, Indiana, United States