Diffuse Large B-cell Lymphoma
Conditions
Keywords
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
Brief 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.
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.
Interventions
DRUGCC-5013 (lenalidomide)
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
DRUGdexamethasone
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.
Sponsors
Celgene Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Rate | One Year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Control Rate | One Year | Number of participants demonstrating complete tumor response, partial tumor response, or stable disease. Study terminated prematurely. Analysis not conducted. |
| Duration of Response | One year | 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. |
| Time to Progression | One year | Time from the start of study drug therapy to the first documentation of disease progression. Study terminated prematurely. Analysis not conducted. |
| Progression-free Survival | One year | 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. |
Countries
Australia, Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lenalidomide in Combination With Dexamethasone Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study discontinued by sponsor | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lenalidomide in Combination With Dexamethasone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age Continuous | 66.7 years STANDARD_DEVIATION 11.42 |
| Region of Enrollment Australia | 4 participants |
| Region of Enrollment Canada | 2 participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 16 Participants |
Outcome results
Primary
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.
Time frame: One Year
Population: Study terminated prematurely. Analyses of efficacy not conducted.
Secondary
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.
Time frame: One year
Secondary
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.
Time frame: One year
Secondary
Time to Progression
Time from the start of study drug therapy to the first documentation of disease progression. Study terminated prematurely. Analysis not conducted.
Time frame: One year
Secondary
Tumor Control Rate
Number of participants demonstrating complete tumor response, partial tumor response, or stable disease. Study terminated prematurely. Analysis not conducted.
Time frame: One Year