Non-Hodgkin’s Relapse Prevention Studied

CancerWise - January 2008

By Darcy De Leon

Patients with a common type of non-Hodgkin's lymphoma are joining a large, multi-center, international clinical trial to determine if the investigational drug enzastaurin can help prevent relapse and increase long-term survival.

Researchers hope to recruit more than 450 patients with diffuse large B-cell lymphoma (DLBCL) to the clinical trial, Preventing Relapse in Lymphoma Using Daily Enzastaurin (PRELUDE), according to the National Institutes of Health's ClinicalTrials.gov website. The study has 154 sites in the United States and more than 20 other countries.

There are currently no treatments to help prevent relapse.

Significance of the study

Approximately 50% of patients with DLBCL relapse within three years after completing the standard treatment, a chemotherapy regimen known as R-CHOP (a combination of the anti-cancer drugs rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone).

“Maintenance therapy is greatly needed because there are currently no therapies to help prevent relapse in high-risk patients with DLBCL who have achieved remission,” says Luis Eduardo Fayad, M.D., principal investigator on the trial at
M. D. Anderson and an associate professor in the Department of Lymphoma and Myeloma.

Goal of the study

The goal of the Phase III trial is to compare a daily dose of enzastaurin to a placebo to determine if enzastaurin can increase survival in patients with DLBCL who are at high risk of relapsing.

Background

A multi-center, Phase II clinical trial published in the Journal of Clinical Oncology [Vol 25, No 13 (May 1), 2007: pp. 1741-1746] concluded that enzastaurin was “well-tolerated and associated with prolonged freedom from progression in a small subset of patients with relapsed or refractory DLBCL.”

Enzastaurin is an investigational drug being studied in different types of cancer including brain, breast, colon, lung, ovarian and prostate.

Study description

Participants in the PRELUDE study will be divided into two groups in which they will receive either enzastaurin or a placebo every day for up to three years. The trial is blinded, meaning patients will not know whether they are receiving the investigational drug or the placebo.

Participants in the trial would have a 66% chance of receiving the experimental drug and a 33% chance of receiving the placebo, Fayad says.

Side effects

The Phase II study reported side effects, including:

• Fatigue
• Headache
• Neuropathy (tingling, numbness)
• Low platelet count

No deaths or discontinuations of treatment due to toxicity were reported.

Eligibility criteria

Participants in the Phase III study must have:

• A clinical diagnosis of DLBCL
• Recently completed R-CHOP therapy
• Achieved remission
• Been diagnosed at high risk for relapse

Patients are excluded if they have:

• Received therapy other than R-CHOP
• Serious medical conditions
• Received radiation to more than one lesion
• Been unable to swallow tablets

M. D. Anderson resources:

• Non-Hodgkin's lymphoma
• Department of Lymphoma and Myeloma