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 RateDuration 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
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