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

Hoosier Cancer Research Network

Status and phase

Terminated

Phase 2

Conditions

Lymphoma, B-Cell

Treatments

Drug: Gemcitabine

Drug: Rituximab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00216164

HOG LYM03-64

Details and patient eligibility

About

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.

Full 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

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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