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

Lilly

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: prednisone; Drug: vincristine; Drug: enzastaurin; Drug: doxorubicin; Drug: rituximab; Drug: cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00451178

9824

H6Q-MC-S028 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Participants must:

1. Have a histologically confirmed diagnosis of DLBCL based on the World Health Organization classification (Harris et al. 1999) at the time of original diagnosis. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the participant is entered. Participants with a prior history of an indolent lymphoma or a histological diagnosis of follicular Grade 3 lymphoma will not be eligible for enrollment.

2. Have received no prior chemotherapy.

3. Have an International Prognostic Index (IPI) score ≥2 at time of original diagnosis.

4. Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology group (ECOG) scale.

5. Have adequate organ function as follows:

   • Hepatic: total bilirubin ≤1.5 times the upper limit of normal (x ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤1.5 x ULN, (≤5 x ULN, if liver involvement).
   • Renal: serum creatinine ≤1.5 x ULN.
   • Adequate bone marrow reserve: platelets ≥75 x 10^9 per Liter (L), absolute neutrophil count (ANC) ≥1.0 x 10^9 per L, unless there is bone marrow involvement.

   Exclusion Criteria:

   Participants must not:

6. Have received treatment within the last 30 days with a drug (not including enzastaurin) that has not received regulatory approval for any indication at the time of study entry.

7. Are receiving concurrent administration of any other systemic anticancer therapy.

8. Are pregnant or breastfeeding.

9. Are unable to swallow tablets.

10. Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

R-CHOP and Enzastaurin

Experimental group

Description:

R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.

Treatment:

Drug: rituximab

Drug: doxorubicin

Drug: cyclophosphamide

Drug: enzastaurin

Drug: vincristine

Drug: prednisone

R-CHOP

Active Comparator group

Description:

R-CHOP includes rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone treatment therapies.

Treatment:

Drug: rituximab

Drug: doxorubicin

Drug: cyclophosphamide

Drug: vincristine

Drug: prednisone