Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Hoosier Oncology Group LYM03-64
18 Years
N/A
Both
Lymphoma, B-Cell
Trial Information
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
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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
· Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Michael Robertson, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Hoosier Oncology Group, LLC
Authority:
United States: Institutional Review Board
Study ID:
HOG LYM03-64
NCT ID:
NCT00216164
Start Date:
April 2005
Completion Date:
March 2007
Related Keywords:
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
Name | Location |
|---|---|
| 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 |
