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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00216164
• Other study ID #: HOG LYM03-64
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: April 28, 2011
• Start date: April 2005
• Est. completion date: March 2007

Study information

• Verified date: April 2011
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab
Rituximab 375 mg/m2, day 1 of 21 day cycle
• Gemcitabine
Gemcitabine 1000 mg/m2, days 1 and 8 of 21 day cycle

Locations

Country	Name	City	State
United States	Elkhart Clinic	Elkhart	Indiana
United States	Oncology Hematology Associates of SW Indiana	Evansville	Indiana
United States	Fort Wayne Oncology & Hematology, Inc	Fort Wayne	Indiana
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Quality Cancer Center (MCGOP)	Indianapolis	Indiana
United States	Center for Cancer Care, Inc., P.C.	New Albany	Indiana
United States	Northern Indiana Cancer Research Consortium	South Bend	Indiana
United States	AP&S Clinic	Terre Haute	Indiana
United States	Providence Medical Group	Terre Haute	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Eli Lilly and Company, Walther Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	· Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.		18 months	No
Secondary	· Evaluate toxicity, time to progression and overall survival.		18 months	Yes

External Links

•   Hoosier Oncology Group Home Page