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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00413036 |
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Date of registration:
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18/12/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
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Scientific title:
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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 |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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217 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00413036 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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France
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Germany
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Italy
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Lei Zhang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Celgene Corporation |
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Key inclusion & exclusion criteria
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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
- Eastern Cooperative Oncology Group (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/mm^3 (1.5*10^9/L).
- Platelet count < 60,000/mm^3 (60*10^9/L).
- Calculated creatinine clearance of <50mL/min
- Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or
Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times
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 Central Nervous System (CNS) lymphoma within the previous 6 months
- History of other malignancies within the past year
- Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lymphoma, Non-Hodgkin's
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Intervention(s)
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Drug: lenalidomide
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Primary Outcome(s)
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Participants Categorized by Best Response as Determined by Central Review
[Time Frame: Up to 1459 days]
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Secondary Outcome(s)
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Progression-free Survival as Determined by Central Review
[Time Frame: Up to 1459 days]
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Time to Progression as Determined by Central Review
[Time Frame: Up to 1459 days]
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Duration of Response as Determined by Central Review
[Time Frame: Up to 1459 days]
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Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review
[Time Frame: Up to 1459 days]
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Secondary ID(s)
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CC-5013-NHL-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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