Lymphoma, B-Cell Clinical Trial
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
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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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