NCT00216164

Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 375 mg/m2, day 1 of 21 day cycle
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2, days 1 and 8 of 21 day cycle

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2005-09-22
• Last updated: 2011-05-02

Locations

9 sites across 1 country: United States