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

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diffuse Large B-cell Lymphoma

Intervention: CC-5013 (lenalidomide) (Drug); dexamethasone (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Andrew Spencer, MD, Principal Investigator, Affiliation: The Alfred Hospital

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.

Clinical Details

Official title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Tumor Response Rate

Secondary outcome:

Tumor Control Rate

Duration of Response

Time to Progression

Progression-free Survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Frankston Hospital, Frankston VIC 3199, Australia

HOCA, South Brisbane QLD 4101, Australia

Border Medical Oncology, Wodonga VIC 3690, Australia

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

Palo Verde Hematology/Oncology, Ltd., Glendale, Arizona 85304, United States

Tower Cancer Research Foundation, Beverly Hills, California 90211, United States

Advanced Medical Specialties, Miami, Florida 33176, United States

Hematology/Oncology Associates of Treasure Coast, Port St. Lucie, Florida 34952, United States

Northwest Georgia Oncology Centers, Marietta, Georgia 30060, United States

Cancer Care & Hematology Specialists of Chicagoland, Arlington Heights, Illinois 60005, United States

Northwestern University, Feinberg School of Medicine, Chicago, Illinois 60611, United States

Rush University Medical Center, Chicago, Illinois 60612, United States

University of Kentucky, Lexington, Kentucky 40536, United States

Southwest Oncology Associates, Lafayette, Louisiana 70503, United States

Washington County Hospital, The Center for Clinical Research, Hagerstown, Maryland 21742, United States

Kalamazoo Hematology & Oncology, Kalamazoo, Michigan 49048, United States

Oncology & Hematology Specialists, PA, Denville, New Jersey 07834, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Northwestern Carolina, Oncology and Hematology PA, Hickory, North Carolina 28602, United States

New Bern Cancer Care, New Bern, North Carolina 28562, United States

James Cancer Hospital, Columbus, Ohio 43210, United States

SouthWest Regional Cancer Center, Austin, Texas 78705, United States

Northern Utah Associates, Ogden, Utah 84403, United States

The Alfred Hospital, Melbourne, Victoria VIC3050, Australia

Additional Information

Starting date: May 2007
Last updated: August 27, 2009

Page last updated: August 23, 2015

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