Trial Outcomes & Findings for Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL) (NCT NCT00267059)
NCT ID: NCT00267059
Last Updated: 2012-08-07
Results Overview
Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.
COMPLETED
PHASE2
45 participants
Evaluated after three 28-day cycles of lenalidomide.
2012-08-07
Participant Flow
Recruitment Period 12/7/05 - 8/7/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.
Forty five patients were registered on this study. Forty four were evaluable. One patient never received treatment.
Participant milestones
| Measure |
Lenalidomide
10 mg/day, orally once a day for 28 days
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=44 Participants
10 mg/day, orally once a day for 28 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated after three 28-day cycles of lenalidomide.Population: Analysis was intention to treat (ITT): Forty four patients received treatment.
Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.
Outcome measures
| Measure |
Lenalidomide
n=44 Participants
10 mg/day, orally once a day for 28 days
|
|---|---|
|
Number of Patients in Overall Response Categories
No Response
|
30 Participants
|
|
Number of Patients in Overall Response Categories
Complete Response
|
3 Participants
|
|
Number of Patients in Overall Response Categories
Complete Response With Nodules
|
1 Participants
|
|
Number of Patients in Overall Response Categories
Partial Response
|
10 Participants
|
Adverse Events
Lenalidomide
Serious adverse events
| Measure |
Lenalidomide
n=44 participants at risk
10 mg/day, orally once a day for 28 days
|
|---|---|
|
Infections and infestations
Pseudomonas Aeruginosa Bactremia
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
General disorders
Pain
|
6.8%
3/44 • Number of events 3 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
4.5%
2/44 • Number of events 2 • 3 years
|
|
General disorders
Death
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Infections and infestations
Pneumonia
|
18.2%
8/44 • Number of events 9 • 3 years
|
|
Infections and infestations
Pneumocystis carinii pneumonia
|
4.5%
2/44 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Mucormycosis
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Infections and infestations
Fever of unknown origin
|
13.6%
6/44 • Number of events 6 • 3 years
|
|
Cardiac disorders
Hypertension
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Cardiac disorders
Hypotension
|
4.5%
2/44 • Number of events 2 • 3 years
|
|
Infections and infestations
Diverticulitis
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Rotavirus
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
General disorders
Tumor Flare
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy Lung
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Immune system disorders
Viral Hepatitis Reactivation
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Criptosporididosis
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Infections and infestations
Prostate Infection
|
2.3%
1/44 • Number of events 1 • 3 years
|
|
Cardiac disorders
Stroke
|
2.3%
1/44 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Lenalidomide
n=44 participants at risk
10 mg/day, orally once a day for 28 days
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
29.5%
13/44 • Number of events 170 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.8%
14/44 • Number of events 103 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
11.4%
5/44 • Number of events 72 • 3 years
|
|
General disorders
Fatigue
|
31.8%
14/44 • Number of events 75 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
6/44 • Number of events 50 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.3%
12/44 • Number of events 43 • 3 years
|
|
General disorders
Tumor Flare
|
34.1%
15/44 • Number of events 33 • 3 years
|
Additional Information
Alessandra Ferrajoli, MD, BS / Associate Professor
The University of Texas M. D. Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place