Trial Outcomes & Findings for Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia (NCT NCT01465230)
NCT ID: NCT01465230
Last Updated: 2014-10-23
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
36 months
Results posted on
2014-10-23
Participant Flow
Participant milestones
| Measure |
Lenalidomide
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Lenalidomide
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=2 Participants
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Participants withdrew from study before primary outcome could be measured
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.
Outcome measures
Outcome data not reported
Adverse Events
Lenalidomide
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide
n=2 participants at risk
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide
|
|---|---|
|
Vascular disorders
Deep Vein Thrombosis
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
Other adverse events
| Measure |
Lenalidomide
n=2 participants at risk
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
Blood and lymphatic system disorders
Decreased Platlets
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
Musculoskeletal and connective tissue disorders
Sciatica Pain
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
Musculoskeletal and connective tissue disorders
Bilateral Hand Spasticity
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
Blood and lymphatic system disorders
Decreased ANC
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
Blood and lymphatic system disorders
Decreased Calcium
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
Blood and lymphatic system disorders
Hypokalemia
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
Blood and lymphatic system disorders
Decreased Neutrophil Count
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
General disorders
Syncope
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
|
Musculoskeletal and connective tissue disorders
Right Groin Pain
|
50.0%
1/2 • Adverse events were collected throughout the length of the study (approximately 1 year and 1/2)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place