Chronic Lymphocytic Leukemia
Conditions
Keywords
chronic lymphocytic leukemia, maintenance therapy
Brief summary
This study will determine whether or not Lenalidomide improves effectiveness of treatment for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the disease (bendamustine and rituximab).
Interventions
DRUGMaintenance lenalidomide
Daily maintenance treatment, oral lenalidomide
Sponsors
Celgene Corporation
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Previous induction treatment with bendamustine and rituximab * 18 or more years of age * chronic lymphocytic leukemia * ECOG performance status less than or equal to 2 * Absolute neutrophile count more than 1,000 * Platelet count more than 70,000
Exclusion criteria
* Serious medical condition that would prevent treatment with lenalidomide * Evidence of tumor lysis syndrome * Any prior treatment with lenalidomide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 36 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lenalidomide Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Lenalidomide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 36 months
Population: Participants withdrew from study before primary outcome could be measured