A Study of Participants With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Participants Who Take R-CHOP Only

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• enzastaurin — DRUG
  1125 milligrams (mg) then 500 mg, oral, daily, six 21-day cycles or up to 3 years
• rituximab — DRUG
  375 milligrams per square meter (mg/m\^2), intravenous (IV), Day 1 every 21 days, six 21-day cycles
• cyclophosphamide — DRUG
  750 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
• doxorubicin — DRUG
  50 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
• vincristine — DRUG
  1.4 mg/m\^2, IV, Day 1 every 21 days, six 21-day cycles
• prednisone — DRUG
  100 mg, oral, Days 1-5, six 21-day cycles

Study Details

To compare R-CHOP plus enzastaurin versus R-CHOP for progression-free survival (PFS) time measured in participants with intermediate and/or high risk for diffuse large B-cell lymphoma (DLBCL) receiving first-line treatment.

Key Dates

Start date

May 31, 2007

Status verified

Jul 2020

Primary completion

Feb 29, 2012

Completion

Jan 31, 2013

Study Design

Enrollment

101 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: R-CHOP and Enzastaurin
  R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.
• Active Comparator: R-CHOP
  R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.

Primary Outcome Measure

Progression-Free Survival (PFS) Time [ Time Frame: Randomization to measured PD or death from any cause (up to 55 months) ]

Locations (25)

Find similar trials in Huntsville, AL

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