Not provided
Not provided
Not provided
Not provided
Not provided
This study was unsuccessful in enrolling the target number of subjects during the funding period.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lenalidomide | Experimental | Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maintenance lenalidomide | Drug | Daily maintenance treatment, oral lenalidomide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Terri L Parker, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06519 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lenalidomide | Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab. Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lenalidomide | Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab. Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants withdrew from study before primary outcome could be measured | Posted | 36 months |
|
|
Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lenalidomide | Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab. Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Vascular disorders | CTC Version 4 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | CTC Version 4 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terri Parker | Yale University | 203-737-5312 | terri.parker@yale.edu |
Not provided
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
| 1 |
| 2 |
| 1 |
| 2 |
| Decreased Platlets | Blood and lymphatic system disorders | CTC Version 4 | Systematic Assessment |
|
| Sciatica Pain | Musculoskeletal and connective tissue disorders | CTC Version 4 | Systematic Assessment |
|
| Bilateral Hand Spasticity | Musculoskeletal and connective tissue disorders | CTC Version 4 | Systematic Assessment |
|
| Decreased ANC | Blood and lymphatic system disorders | CTC Version 4 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTC Version 4 | Systematic Assessment |
|
| Decreased Calcium | Blood and lymphatic system disorders | CTC Version 4 | Systematic Assessment |
|
| Hypokalemia | Blood and lymphatic system disorders | CTC Version 4 | Systematic Assessment |
|
| Decreased Neutrophil Count | Blood and lymphatic system disorders | CTC Version 4 | Systematic Assessment |
|
| Syncope | General disorders | CTC Version 4 | Systematic Assessment |
|
| Right Groin Pain | Musculoskeletal and connective tissue disorders | CTC Version 4 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |