Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Hoosier Oncology Group LYM03-64
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
Subgroup 3. Refractory to first line chemotherapy and/or 1 (one) salvage chemotherapy
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
- ANC ≥ 1,000/mm3·
- Platelets ≥ 100,000/mm3
- 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
- Serum creatinine ≤ 2.0 mg/dl (except for patients on dialysis)
- Not specified
- Not specified
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
· Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.
Michael Robertson, M.D.
Hoosier Oncology Group, LLC
United States: Institutional Review Board
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Oncology Hematology Associates of SW Indiana||Evansville, Indiana 47714|
|Providence Medical Group||Terre Haute, Indiana 47802|
|Elkhart Clinic||Elkhart, Indiana 46515|
|Quality Cancer Center (MCGOP)||Indianapolis, Indiana 46202|
|Center for Cancer Care, Inc., P.C.||New Albany, Indiana 47150|
|AP&S Clinic||Terre Haute, Indiana 47804|
|Fort Wayne Oncology & Hematology, Inc||Fort Wayne, Indiana 46815|