Clinical trial NCT00216164: Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, B-Cell
Keywords: Lymphoma
Lead sponsor: Hoosier Cancer Research Network
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Walther Cancer Institute
First posted: 2005-09-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: · Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.
timeFrame: 18 months
Secondary outcomes:
measure: · Evaluate toxicity, time to progression and overall survival.
timeFrame: 18 months
Other outcomes:
Locations:
city: Elkhart
country: United States
facility: Elkhart Clinic
state: Indiana
city: Evansville
country: United States
facility: Oncology Hematology Associates of SW Indiana
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Oncology & Hematology, Inc
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Quality Cancer Center (MCGOP)
state: Indiana
city: New Albany
country: United States
facility: Center for Cancer Care, Inc., P.C.
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Terre Haute
country: United States
facility: Providence Medical Group
state: Indiana
city: Terre Haute
country: United States
facility: AP&S Clinic
state: Indiana
Study officials:
affiliation: Hoosier Oncology Group, LLC
name: Michael Robertson, M.D.
role: STUDY_CHAIR
References: