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

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Detailed Description
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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.

Official Title
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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

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Drug: CC-5013 (lenalidomide)
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: CC-5013 (lenalidomide)<br>* Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle<br>* Other names: Revlimid;Drug: dexamethasone<br>* Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.<br>* Other names: Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response Rate | Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53). Study terminated prematurely. Analysis not conducted. | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Control Rate | Number of participants demonstrating complete tumor response, partial tumor response, or stable disease. Study terminated prematurely. Analysis not conducted. | One Year | 
| Duration of Response | Time from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma. Study terminated prematurely. Analysis not conducted. | One year | 
| Time to Progression | Time from the start of study drug therapy to the first documentation of disease progression. Study terminated prematurely. Analysis not conducted. | One year | 
| Progression-free Survival | Time from the start of study drug therapy to the first observation of disease progression or death due to any cause. Study terminated prematurely. Analysis not conducted. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celgene, Revlimid, Lenalidomide, Diffuse Large B-cell lymphoma, Non-Hodgkins lymphoma, CC-5013, Response Rate, Tumor Control Rate, Duration of Response, Time to Progression, Progression-free survival and safety