A Study of Revlimid for Treatment of Non-Hodgkin's Lymphoma
Information source: Celgene Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, Non-Hodgkin's
Intervention: lenalidomide (Drug); lenalidomide (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Celgene Corporation
Summary
Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day
cycle. Treatment will continue until disease progression, or unacceptable adverse events
develop
Clinical Details
Official title: A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) In Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: response rate
Secondary outcome: reported side effects
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Key Inclusion criteria
- Biopsy proven aggressive non-hodgkin's lymphoma
- Follicular center lymphoma Grade 3.
- Diffuse large B-cell lymphoma.
- Mantle cell lymphoma.
- Transformed lymphoma.
- Relapsed or refractory to previous therapy for lymphoma
- At least one prior combination chemotherapy regime
- 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
Key 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).
- Calculated creatinine clearance of <50mL/min
- Serum SGOT/AST or SGPT/ALT 5. 0 x upper limit of normal (ULN).
- Serum total bilirubin > 2. 0 mg/dL (34 µmol/L)/conjugated bilirubin >0. 8mg/dL.
- Subjects who are candidates for and willing to undergo an autologous stem cell
transplant.
- History of active CNS lymphoma within the previous 6 months
- History of other malignancies within the past year
- Positive HIV or active Hepatitis B or C
Locations and Contacts
Research Site, Homburg, Germany
Research Site, Heidelberg, Germany
Research Site, Goettingen, Germany
Research Site, Koeln, Germany
Research Site, Berlin, Germany
Research Site, Valencia, Spain
Northwest Alabama Cancer Center, PC, Muscle Shoals, Alabama 35661, United States
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States
Access Clinical Research, Rancho Mirage, California 92270, United States
Kaiser Permanente Medical Group, San Diego, California 92120, United States
Hematology Oncology Associates of Central Brevard, Rockledge, Florida 32955, United States
Pasco Hernando Oncology Associates, Brooksville, Florida 34613, United States
Sylvester Cancer Center/ Univeristy of Miami, Miami, Florida 33136, United States
Cancer Care Center, Inc., New Albany, Indiana 47150, United States
Ochsner Clinic Foundation, Baton Rouge, Louisiana 70809, United States
Michigan Hematology and Oncology Institute, Southgate, Michigan 48195, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
University of Nebraska, Omaha, Nebraska 68198, United States
Center for Cancer and Hematologic Disease, Cherry Hill, New Jersey 08003, United States
Our Lady of Mercy Cancer Center, Bronx, New York 10466, United States
London Health Science Center, London, Ontario, Canada
HIllman Cancer Center -UPMC, Pittsburg, Pennsylvania 15232, United States
Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada
Palmetto Hematology Oncology, Spartanburg, South Carolina 29303, United States
Additional Information
Starting date: June 2006
Ending date: June 2009
Last updated: April 21, 2008
|
