A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

Study Overview
=================
Brief 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

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

Conditions
-----------------
Lymphoma, Non-Hodgkin's

Intervention / Treatment
-----------------
* Drug: lenalidomide


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lenalidomide<br>25 mg oral lenalidomide once daily on Days 1-21 every 28 days | Drug: lenalidomide<br>* once daily oral capsule<br>* Other names: Revlimid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Categorized by Best Response as Determined by Central Review | Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article. Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy. Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow. Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson. Stable Disease(SD): Less than PR, but not progressive disease. Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD. | Up to 1459 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response as Determined by Central Review | Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma. For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting. | Up to 1459 days | 
| Time to Progression as Determined by Central Review | Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression. Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article. Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD. | Up to 1459 days | 
| Progression-free Survival as Determined by Central Review | Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first. Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article. Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD. | Up to 1459 days | 
| Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review | Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article. Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy. Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow. Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson. Stable Disease(SD): Less than PR, but not progressive disease. | Up to 1459 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celgene, Revlimid, CC-5013, Non-hodgkin's lymphoma, Lenalidomide, CC5013, NHL