Chemotherapy for Participants With Lymphoma

Conditions

• Lymphoma, Large Cell, Diffuse

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• enzastaurin — DRUG
  1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
• gemcitabine — DRUG
  1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles
• rituximab — DRUG
  375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles
• oxaliplatin — DRUG
  100 mg/m², IV, once every two weeks, four to eight 2 week cycles

Study Details

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.

Key Dates

Start date

Feb 28, 2007

Status verified

Jul 2020

Primary completion

Nov 30, 2009

Completion

Nov 30, 2012

Study Design

Enrollment

68 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)

Primary Outcome Measure

Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment [ Time Frame: First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 1 Year ]