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Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Hoosier Oncology Group LYM03-64


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, B-Cell

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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 CenterIndianapolis, Indiana  46202-5265
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Providence Medical GroupTerre Haute, Indiana  47802
Elkhart ClinicElkhart, Indiana  46515
Quality Cancer Center (MCGOP)Indianapolis, Indiana  46202
Center for Cancer Care, Inc., P.C.New Albany, Indiana  47150
AP&S ClinicTerre Haute, Indiana  47804
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815