A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 2

Terminated

Conditions: Diffuse Large B-cell Lymphoma

Interventions: Drug: CC-5013 (lenalidomide)
Drug: dexamethasone

Registration Number: NCT00474188

Lead Sponsor: Celgene Corporation

Brief Summary: To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Detailed Description: Non-Hodgkin's lymphoma (NHL) can be divided into two general prognostic groups: the indolent lymphomas and the aggressive lymphomas. Indolent lymphomas have a relatively good prognosis, with median survival time as long as 10 years, but they are not usually curable in advanced stages. Aggressive NHL constitutes about half of all cases of NHL in North America and Western Europe. Of the aggressive lymphomas, diffuse large B-cell lymphoma (DLBCL) is the most common type, accounting for up to 30 percent of newly diagnosed cases. The aggressive type of NHL has a shorter natural history; approximately 50-60% of these subjects can be cured with combination chemotherapy regimens. Even with recent advances, many patients with advanced stage DLBCL are not cured with conventional therapy. This leaves a subset of subjects who will eventually relapse or who are refractory to treatment.

Due to the variation in the clinical behavior of the different types of aggressive NHL, it is important to test lenalidomide in DLBCL. Other studies are addressing the activity of lenalidomide in the other types of aggressive lymphomas, as well as in indolent NHL. It is important to test lenalidomide in combination therapy. This study is focused on treating subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral dexamethasone.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 26

Inclusion Criteria

Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
ECOG performance score of 0,1 or 2
Willing to follow the pregnancy precautions

Exclusion Criteria

Any of the following laboratory abnormalities.
Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
Platelet count < 60,000/mm3 (60 x 109/L).
Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
Serum total bilirubin > 2.0 mg/dL (34 µmol/L).
Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
History of active CNS lymphoma within the previous 3 months
Subjects not willing or unable to take DVT prophylaxis
History of other malignancies within the past year
Positive HIV or active Hepatitis B or C

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	CC-5013 (lenalidomide)	-
Single Arm	dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Tumor Response Rate	One Year	Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53). Study terminated prematurely. Analysis not conducted.

Secondary Outcome Measures

Name	Time	Method
Tumor Control Rate	One Year	Number of participants demonstrating complete tumor response, partial tumor response, or stable disease. Study terminated prematurely. Analysis not conducted.
Duration of Response	One year	Time from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma. Study terminated prematurely. Analysis not conducted.
Time to Progression	One year	Time from the start of study drug therapy to the first documentation of disease progression. Study terminated prematurely. Analysis not conducted.
Progression-free Survival	One year	Time from the start of study drug therapy to the first observation of disease progression or death due to any cause. Study terminated prematurely. Analysis not conducted.

Trial Locations

Locations (24): Washington County Hospital, The Center for Clinical Research
🇺🇸
Hagerstown, Maryland, United States
Oncology & Hematology Specialists, PA
🇺🇸
Denville, New Jersey, United States
Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
Kalamazoo Hematology & Oncology
🇺🇸
Kalamazoo, Michigan, United States
Northern Utah Associates
🇺🇸
Ogden, Utah, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
New Bern Cancer Care
🇺🇸
New Bern, North Carolina, United States
The Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
Frankston Hospital
🇦🇺
Frankston, Australia
HOCA
🇦🇺
South Brisbane, Australia
James Cancer Hospital
🇺🇸
Columbus, Ohio, United States
Southwest Oncology Associates
🇺🇸
Lafayette, Louisiana, United States
Border Medical Oncology
🇦🇺
Wodonga, Australia
SouthWest Regional Cancer Center
🇺🇸
Austin, Texas, United States
Northwestern Carolina, Oncology and Hematology PA
🇺🇸
Hickory, North Carolina, United States
Advanced Medical Specialties
🇺🇸
Miami, Florida, United States
Northwestern University, Feinberg School of Medicine
🇺🇸
Chicago, Illinois, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Palo Verde Hematology/Oncology, Ltd.
🇺🇸
Glendale, Arizona, United States
Tower Cancer Research Foundation
🇺🇸
Beverly Hills, California, United States
Hematology/Oncology Associates of Treasure Coast
🇺🇸
Port St. Lucie, Florida, United States
Northwest Georgia Oncology Centers
🇺🇸
Marietta, Georgia, United States
Cross Cancer Institute
🇨🇦
Edmonton, Alberta, Canada
Cancer Care & Hematology Specialists of Chicagoland
🇺🇸
Arlington Heights, Illinois, United States