Chemotherapy for Participants With Lymphoma

Lilly

Status and phase

Completed

Phase 2

Conditions

Lymphoma, Large Cell, Diffuse

Treatments

Drug: gemcitabine

Drug: rituximab

Drug: oxaliplatin

Drug: enzastaurin

Study type

Interventional

Funder types

Industry

Identifiers

H6Q-MC-S013 (Other Identifier)

9819

Details and patient eligibility

About

The primary purpose of this study is to help answer the following research questions:

To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer.
To assess for any side effects that might be associated with enzastaurin and R-GEMOX .
To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body.
To look at the level of enzastaurin in the body and how long it remains.

Enrollment

68 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of DLBCL or transformed (cluster differentiation 20 [CD20]+) indolent lymphoma
Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or participants who have not progressed after stable disease (SD) obtained in 1st- or 2nd-line.
Measurable disease (lymph node greater than 1.5 cm)
Adequate organ function
Greater than or equal to 60 years or less than 60 (but greater than or equal to 18 years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT)

Exclusion criteria