Clinical Research Details

Title:

A Phase II, Multicenter, Single-Arm, Open-Label Study to Determine the Efficacy and Safety of Single-Agent Lenalidomide (Revlimid) in Participants with Mantle Cell Non-Hodgkin’s Lymphoma Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib.

Purpose:

To determine the tumor response and duration of response of lenalidomide monotherapy in participants with Mantle Cell Non-Hodgkin’s Lymphoma (MCL) who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.

To evaluate the safety of lenalidomide monotherapy in participants with MCL who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.

To determine the CR, time to progression, time to treatment failure, progression-free survival and overall survival of lenalidomide monotherapy in participants with MCL who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib.

Study Number:

201512031809

Number of Patients:

133

Elgibility:

Participants must be older than 18 years of age with biopsy-proven mantle cell non-Hodgkin’s lymphoma.

Participants must have received all of the following agents (alone or in combination): anthracycline or mitoxantrone; cyclosphosphamide; rituximab; bortezomib.

Participants must have documented relapsed or refractory or PD after treatment with bortezomib.

Participants must have measurable disease on CT.

Treatment:

You will take a lenalidomide orally daily for 21 days every 28 days. The dose may be adjusted depending on lab values.

Principal Investigator:

Enrollment Phone:

(708) 327-3223